FDA Drug Adverse Event Reports Sample
Contract version 20260926191257-e93d4b3eac5e
- Detected
- 2026-09-26T19:12:57+00:00
- Source updated
- unknown
- Rows
- 100
Source Files For 20260926191257-e93d4b3eac5e
- event.json: source
Open Data Contract YAML
dataset_id: fda-drug-adverse-events
title: FDA Drug Adverse Event Reports Sample
description: FDA Drug Adverse Event Reports Sample discovered from api.fda.gov. Bounded
source query (limit=100); completeness is not assumed.
source_name: api.fda.gov
source_url: https://api.fda.gov/drug/event.json?limit=100
update_frequency: daily
next_scan_at: '2026-09-26T23:12:57.485613+00:00'
license:
name: U.S. Food and Drug Administration website policy
url: https://www.fda.gov/about-fda/about-website/website-policies
tags:
- api.fda.gov
- drugs
geography:
- United States
revisions:
- revision_id: 20260926191257-e93d4b3eac5e
detected_at: '2026-09-26T19:12:57+00:00'
source_updated_at: null
context: event.json detected from event.json.
assets:
- asset_id: asset-585f3120b49f21d0
name: event.json
source_url: https://api.fda.gov/drug/event.json?limit=100
media_type: application/json; charset=utf-8
content_hash: 585f3120b49f21d06370906a2dc7bf10bd513dda8c40605d36458e1c56ca5dcf
size_bytes: 2869367
parent_archive_id: null
row_count: 100
headers:
- companynumb
- duplicate
- fulfillexpeditecriteria
- occurcountry
- patient
- primarysource
- primarysourcecountry
- receiptdate
- receiptdateformat
- receivedate
- receivedateformat
- receiver
- reportduplicate
- reporttype
- safetyreportid
- safetyreportversion
- sender
- serious
- seriousnessdeath
- seriousnessdisabling
- seriousnesshospitalization
- seriousnesslifethreatening
- seriousnessother
- transmissiondate
- transmissiondateformat
sample_rows:
- safetyreportid: 5801206-7
transmissiondateformat: '102'
transmissiondate: '20090109'
serious: '1'
seriousnessdeath: '1'
receivedateformat: '102'
receivedate: '20080707'
receiptdateformat: '102'
receiptdate: '20080625'
fulfillexpeditecriteria: '1'
companynumb: JACAN16471
primarysource:
reportercountry: CANADA
qualification: '3'
sender:
senderorganization: FDA-Public Use
receiver: null
patient:
patientonsetage: '26'
patientonsetageunit: '801'
patientsex: '1'
patientdeath:
patientdeathdateformat: null
patientdeathdate: null
reaction:
- reactionmeddrapt: DRUG ADMINISTRATION ERROR
- reactionmeddrapt: OVERDOSE
drug:
- drugcharacterization: '1'
medicinalproduct: DURAGESIC-100
drugauthorizationnumb: 019813
drugadministrationroute: '041'
drugindication: DRUG ABUSE
- safetyreportversion: '1'
safetyreportid: '10003300'
primarysourcecountry: US
transmissiondateformat: '102'
transmissiondate: '20141002'
reporttype: '1'
serious: '1'
seriousnessdisabling: '1'
receivedateformat: '102'
receivedate: '20140306'
receiptdateformat: '102'
receiptdate: '20140306'
fulfillexpeditecriteria: '2'
companynumb: '1289378'
duplicate: '1'
reportduplicate:
duplicatesource: GENENTECH
duplicatenumb: '1289378'
primarysource:
reportercountry: US
qualification: '5'
sender:
sendertype: '2'
senderorganization: FDA-Public Use
receiver:
receivertype: '6'
receiverorganization: FDA
patient:
patientonsetage: '77'
patientonsetageunit: '801'
patientsex: '2'
reaction:
- reactionmeddraversionpt: '17.0'
reactionmeddrapt: Vomiting
- reactionmeddraversionpt: '17.0'
reactionmeddrapt: Diarrhoea
- reactionmeddraversionpt: '17.0'
reactionmeddrapt: Arthralgia
- reactionmeddraversionpt: '17.0'
reactionmeddrapt: Headache
drug:
- drugcharacterization: '1'
medicinalproduct: BONIVA
drugbatchnumb: H6200HO3
drugauthorizationnumb: 021858
drugstructuredosagenumb: '3'
drugstructuredosageunit: '003'
drugdosagetext: 3 MG, 1 IN 3 M, INTRAVENOUS (NOT OTHERWISE SPECIFIED)
drugadministrationroute: '042'
drugindication: OSTEOPOROSIS
drugstartdateformat: '102'
drugstartdate: '20130913'
- safetyreportversion: '1'
safetyreportid: '10003301'
primarysourcecountry: US
transmissiondateformat: '102'
transmissiondate: '20141002'
reporttype: '1'
serious: '1'
seriousnessother: '1'
receivedateformat: '102'
receivedate: '20140228'
receiptdateformat: '102'
receiptdate: '20140228'
fulfillexpeditecriteria: '2'
companynumb: US-JNJFOC-20130719067
duplicate: '1'
reportduplicate:
duplicatesource: JANSSEN
duplicatenumb: US-JNJFOC-20130719067
primarysource:
reportercountry: US
qualification: '5'
sender:
sendertype: '2'
senderorganization: FDA-Public Use
receiver:
receivertype: '6'
receiverorganization: FDA
patient:
patientsex: '2'
reaction:
- reactionmeddraversionpt: '17.0'
reactionmeddrapt: Dyspepsia
- reactionmeddraversionpt: '17.0'
reactionmeddrapt: Renal impairment
drug:
- drugcharacterization: '1'
medicinalproduct: IBUPROFEN
drugauthorizationnumb: '17463'
drugindication: PRODUCT USED FOR UNKNOWN INDICATION
drugrecurreadministration: '3'
drugadditional: '3'
openfda:
application_number:
- ANDA078682
- ANDA077349
- 505G(a)(3)
- ANDA079174
- ANDA074937
- ANDA210602
- ANDA202312
- ANDA075217
- ANDA091355
- ANDA075010
- ANDA076359
- ANDA209179
- ANDA210755
- NDA020944
- ANDA091239
- ANDA075682
- NDA020589
- ANDA202413
- ANDA091237
- NDA020516
- ANDA210149
- ANDA072096
- ANDA207095
- ANDA220239
- ANDA206568
- ANDA217261
- ANDA204469
- ANDA207753
- ANDA079233
- ANDA079205
- ANDA206999
- ANDA075139
- NDA020402
- ANDA091625
- ANDA213794
- NDA022348
- ANDA079129
- ANDA215318
- ANDA208865
- M
- ANDA078329
- ANDA078558
- ANDA209204
- ANDA214789
- NDA018989
- ANDA071268
- ANDA074916
- ANDA071333
- NDA020603
- ANDA076460
- ANDA202300
- ANDA209207
- ANDA203599
- ANDA215311
- ANDA071334
- ANDA209178
- ANDA071935
- M013
- ANDA079058
- ANDA072199
- NDA020812
- ANDA071265
- ANDA090796
- ANDA071335
- ANDA211666
- ANDA215777
- ANDA074978
- ANDA076925
- NDA020267
- M012
- ANDA213506
brand_name:
- IBUPROFEN
- CAREONE IBUPROFEN
- GOOD REMEDIES IBUPROFEN 200 MG
- IBUPROFEN CHILDRENS
- CHILDRENS IBUPROFEN ORAL SUSPENSION, DYE FREE
- INFANTS DYE FREE IBUPROFEN
- LEADER CHILDRENS IBUPROFEN
- GOOD SENSE CHILDRENS IBUPROFEN
- CABINET PAIN RELIEVER AND FEVER REDUCER
- CHILDRENS IBUPROFEN
- CONCENTRATED IBUPROFEN INFANTS
- JUNIOR STRENGTH ADVIL
- IBU
- MEDIQUE IPRIN
- MEDI-FIRST IBUPROFEN
- MEDI-FIRST PLUS IBUPROFEN
- DOVER ADDAPRIN
- GREEN GUARD IBUPRO RELIEF
- CHILDRENS ADVIL
- CARE ONE IBUPROFEN CHILDRENS
- CHILDRENS MOTRIN
- CHILDRENS IBUPROFEN ORAL SUSPENSION DYE FREE
- ULINE IBUPROFEN
- GOOD NEIGHBOR PHARMACY IBUPROFEN
- UP AND UP CHILDRENS IBUPROFEN
- DYE FREE CHILDRENS IBUPROFEN
- BASIC CARE IBUPROFEN
- XPECT IBUPROFEN
- IBUPROFEN INFANTS
- IBUPROFEN MINIS
- KOSHER MEDS
- EQUATE IBUPROFEN
- FOSTER AND THRIVE CHILDRENS IBUPROFEN IB
- DYE-FREE PAIN RELIEF
- IBUPROFEN MINI DYE FREE
- DOLEX FLEX
- IBUPAK
- DYE FREE IBUPROFEN
- ADVIL LIQUI-GELS
- BETR PAIN RELIEF
- EQUALINE CHILDRENS IBUPROFEN
- CHILDRENS IBUPROFEN BUBBLEGUM
- CHILDRENS IBUPROFEN FRUIT
- CHILDRENS IBUPROFEN BLUE RASPBERRY
- CHILDRENS IBUPROFEN GRAPE
- IBUPROFEN IB
- KOSHER MEDS DYE-FREE IBUPROFEN
- TOPCARE CHILDRENS IBUPROFEN
- REXALL IBUPROFEN
- ADVIL MIGRAINE
- IBUPROFEN 200MG
- DG HEALTH IBUPROFEN
- CALDOLOR
- EQUATE IBUPROFEN CHILDRENS
- GOOD NEIGHBOR PHARMACY CHILDRENS IBUPROFEN
- BERKLEY AND JENSEN IBUPROFEN
- EQUALINE IBUPROFEN
- HENRY SCHEIN IBUPROFEN
- PROFEN IB INFANTS
- IBUPROFEN MIGRAINE
- ASSURED IBUPROFEN
- UP AND UP IBUPROFEN
- CAREONE CHILDRENS IBUPROFEN
- CHILDRENS IBUPROFEN ORAL SUSPENSION
- BASIC CARE CHILDRENS IBUPROFEN
- PROFEN IB CHILDRENS
- BASIC CARE INFANTS IBUPROFEN
- ADVIL
- EQUALINE IBUPROFEN CHILDRENS
- FOSTER AND THRIVE IBUPROFEN
- IBUPROFEN PAIN RELEIVER/ FEVER REDUCER
- IBUPROFEN 24/7 LIFE BY 7-ELEVEN
- LEADER IBUPROFEN
- GOOD SENSE IBUPROFEN CHILDRENS
- INFANTS MOTRIN
- IBUPROFEN THOMPSON
- DYE-FREE IBUPROFEN
- IBUPROFEN DYE FREE
- MOTRIN INFANTS
- IBUPROFEN PAIN RELIEVER/FEVER REDUCER
- PAIN RELIEF IBUPROFEN
- IBUPROFEN IMMEDIATE RELEASE
- PROFEN IB
- MOTRIN IB
- BETR REMEDIES IBUPROFEN
- CHILDRENS IBUPROFEN 572
- KIRKLAND SIGNATURE IBUPROFEN
- GOOD SENSE IBUPROFEN
- IBUPROFEN 200 MG
- CHILDRENS IBUPROFEN 100
- CHILDRENS FLANAX ORAL
- AMAZON BASIC CARE IBUPROFEN
- TOPCARE IBUPROFEN
- CHILDRENS IBUPROFEN ORAL SUSPENSION ORIGINAL BERRY FLAVOR
- UP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN
- COUNTERACT IB
- SIGNATURE CARE CHILDRENS IBUPROFEN
- PAIN RELIEF
- CHILDRENS IBUPROFEN BUBBLEGUM DYE FREE
- RIGHT REMEDIES IBUPROFEN 200 MG
- UNISHIELD IBUPROFEN
- IBUPROFEN CA
- DYE-FREE IBUPROFEN 200
- IBUPROFEN 100
- IBUPROFEN 250
- INFANTS IBUPROFEN
- IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER
- CARE ONE IBUPROFEN
- CHILDRENS IBUPROFEN ORAL SUSPENSION, BUBBLE GUM
- GREEN GUARD IBUPROFEN RELIEF
- KIRKLAND SIGNATURE IBUPROFEN IB
- PEDIACARE CHILDRENS IBUPROFEN BERRY
- GOOD SENSE IBUPROFEN INFANTS
- INFANTS ADVIL
- CIRCLE K IBUPROFEN
- IBUPROFEN INFANTS DROPS
- CVS IBUPROFEN
- SIGNATURE CARE IBUPROFEN
- PARENTS CHOICE INFANTS IBUPROFEN
- LEADER INFANTS IBUPROFEN
- GOOD NEIGHBOR PHARMACY IBUPROFEN CHILDRENS
- TOPCARE INFANTS IBUPROFEN
- GOODNOW PAIN RELIEF
- CHILDRENS IBUPROFEN 100 DYE FREE
- FLEX-PRIN
- PAIN RELIEF - IBUPROFEN 200 MG
- DIRECT SAFETY IBUPROFEN
- IBUPROFEN, LIL DRUG STORE
- MEDIQUE AT HOME IPRIN
- IBUPROFEN FAST RELIEF MEDICINE FOR PAIN
- MIGRAINE RELIEF
- LIL DRUG STORE IBUPROFEN
- MCKESSON IBUPROFEN 200 MG
- IBUWIN FORTE
- IBUPROFEN 200
- DG HEALTH CHILDRENS IBUPROFEN
- IBUPROFEN, CIRCLE K, 50CT
- IBUPROFEN, CASEYS, 50CT
- IBUPROFEN, LIL DRUG STORE, 50CT
- IBUPROFEN, LIL DRUG STORE, 24CT
- MOTRIN IB, TRAVEL BASIX
- MOTRIN IB, CVP HEALTH
- 365 WHOLE FOODS MARKET IBUPROFEN
- CAREALL IBUPROFEN
- GOOD SENSE INFANTS IBUPROFEN
- VALUMEDS IBUPROFEN
- DOLEX CHILDREN
- IBUPROFEN DYE-FREE
- MOTRIN IB MIGRAINE
- FAST PAIN RELIEF
- FOSTER AND THRIVE INFANTS IBUPROFEN
generic_name:
- IBUPROFEN
- IBUPROFEN CAPSULES 200 MG
- IBUPROFEN TABLETS USP, 200MG
- IBUPROFEN TABLET, FILM COATED
- IBUPROFEN ORAL
- IBUPROFEN 200MG
- IBUPFROFEN
- IBUPROFEN TABLET, FILM-COATED
- IBUPROFEN 200 MG
- IBUPROFEN CAPSULE
manufacturer_name:
- DOLGENCORP INC
- American Sales Company
- Strive Pharmaceuticals Inc.
- Rite Aid Corporation
- Dolgencorp, Inc.
- HyVee Inc
- Best Choice
- Harris Teeter
- Kroger Company
- Cardinal Health 110, LLC. dba Leader
- PuraCap Pharmaceutical LLC
- NUVICARE LLC
- Geritrex LLC
- L. Perrigo Company
- Spirit Pharmaceutical LLC
- Meijer, Inc.
- TWIN MED LLC
- Better Living Brands, LLC
- Wal-Mart Stores, Inc.
- Haleon US Holdings LLC
- SAM'S WEST INC
- Dr. Reddy's Laboratories Limited
- Unifirst First Aid Corporation
- Chartwell RX, LLC
- CVS Pharmacy
- TIME CAP LABORATORIES,INC
- Kenvue Brands LLC
- Aurohealth LLC
- AptaPharma Inc.
- Chain Drug Marketing Association Inc.
- Uline
- Breeden Brothers, LLC
- FSA STORE INC.
- Shield Pharmaceuticals Corp
- Amerisource Bergen
- Target Corporation
- CVS
- Amazon.com Services LLC
- Advagen Pharma Ltd.
- WALGREEN COMPANY
- Cintas Corporation
- Sun Pharmaceutical Industries, Inc.
- EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
- Mollec Inc
- INGLES MARKETS, INC.
- BJWC
- Pioneer Life Sciences, LLC
- Wal-Mart Stores Inc
- Strategic Sourcing Services LLC
- Bionpharma Inc.
- Grocery Outlet, Inc.
- Randob Labs., Ltd.
- CHAIN DRUG MARKETING ASSOCIATION INC.
- Amneal Pharmaceuticals of New York LLC
- Winco Foods, LLC
- Walgreens
- Pharmadel LLC
- RETAIL BUSINESS SERVICES , LLC.
- PureTek Corporation
- CHAIN DRUG MARKETING ASSOCIATION INC
- Lil Drug Store Products, Inc
- H E B
- Live Betr LLC
- Softgel Healthcare Private Limited
- United Natural Foods, Inc. dba UNFI
- Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
- Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- Granules India Limited
- Guardian Drug Company
- WINCO FOODS, LLC
- NorthStar Rx LLC
- Major Pharmaceuticals
- Topco Associates LLC
- Dolgencorp, LLC
- Allegiant Health
- Walgreen Company
- Care One (American Sales Company)
- L.N.K. International, Inc.
- Retail Business Services, LLC
- Geri-Care Pharmaceutical Corp
- Dolgencorp Inc
- Cumberland Pharmaceuticals Inc.
- GOODSENSE
- Family Dollar (FAMILY WELLNESS)
- Westminster Pharmaceuticals, LLC
- Chain Drug Marketing Association, Inc.
- VALU MERCHANDISERS COMPANY
- TIME CAP LABORATORIES, INC.
- Spirit Pharmaceuticals LLC
- WR Group, Inc.
- BETTER LIVING BRANDS, LLC
- Rugby Laboratories, Inc.
- HART Health
- Henry Schein Inc.
- MARKSANS PHARMA LIMITED
- Topco Associates, LLC
- WALGREENS
- Publix Super Markets Inc
- SOLA Pharmaceuticals, LLC
- Meijer Distribution Inc
- Best Choice (Valu Merchandisers Company)
- TOPCO ASSOCIATES LLC
- Trifecta Pharmaceuticals USA LLC
- AMERISOURCE BERGEN
- RITE AID
- PAI Holdings, LLC dba PAI Pharma
- TOP CARE (Topco Associates LLC)
- Marc Glassman, Inc.
- Chain Drug Consortium
- RITE AID CORPORATION
- HEB
- Amneal Pharmaceuticals LLC
- Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
- Pharmaceutical Associates, Inc.
- Amneal Pharmaceuticals NY LLC
- KROGER COMPANY
- Lil' Drug Store Products, Inc.
- FSA Store Inc. (Caring Mills)
- PURACAP PHARMACEUTICAL LLC
- Thompson Safety
- FSA Store Inc. (Caring Mill)
- PLD Acquisitions LLC DBA Avma Pharma Solutions
- Cardinal Health 110, LLC. DBA Leader
- Lidl US LLC
- BluePoint Laboratories
- WALMART INC.
- BETTER LIVING BRANDS LLC.
- Sam's West, Inc
- MARC GLASSMAN, INC.
- Strides Pharma Inc
- Chalkboard Health
- TIME CAP LABORATORIES, INC
- Family Dollar Services, Inc.
- BJWC (Berkley & Jensen / BJ's)
- Costco Wholesale Company
- Safeway
- RETAIL BUSINESS SERVICES,LLC.
- Discount Drug Mart
- Basic Drugs, Inc.
- Padagis Israel Pharmaceuticals Ltd
- Strides Pharma Science Limited
- AiPing Pharmaceutical, Inc.
- DEMOULAS SUPERMARKETS INC.
- ARMY AND AIR FORCE EXCHANGE SERVICE
- Belmora LLC
- The Kroger Co.
- WALGREEN CO.
- Gobrands, Inc. (Goodnow)
- Puro Pharma Inc.
- Aurobindo Pharma Limited
- Melaleuca, Inc
- Costco Wholesale
- P & L Development, LLC
- Albertsons Companies
- Discount Drug Mart, Inc
- PROSTAT FIRST AID
- Wildman Business Group
- Unishield
- MEIJER DISTRIBUTION INC.
- Granules Pharmaceuticals Inc.
- TARGET CORPORATION
- Ascend Laboratories, LLC
- Safeway, Inc.
- CVS Pharmacy. Inc.
- Chain Drug Consortium, LLC
- JHK Inc dba American Safety & First Aid
- Harris Teeter, LLC
- Demoulas Super Markets, Inc
- ADVANCED FIRST AID, INC.
- Sam's West Inc
- Family Dollar Services Inc
- DISCOUNT DRUG MART
- Unifirst First Aid
- RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
- AMERIFOODS TRADING COMPANY
- Contract Pharmacal Corp.
- SPIRIT PHARMACEUTICALS,LLC
- DOLGENCORP, LLC
- Bi-Mart
- SKYA HEALTH, LLC
- Family Dollar
- Gobrands, Inc
- CHAIN DRUG MARKETING ASSOCIATION, INC.
- Provision Medical Products
- CVS Pharmacy.Inc.
- Health Pharma USA LLC
- Strategic Sourcing Services, LLC
- Conney Safety Products, LLC
- Lil' Drug Store products, Inc.
- Sam's West, Inc.
- COSTCO WHOLESALE CORPORATION
- WALGREENS CO.
- AAA Pharmaceutical, Inc.
- EQUATE (WAL-MART STORES, INC.)
- EXELAN PHARMACEUTICALS, INC.
- HYVEE INC
- Salado Sales, Inc.
- Actavis Pharma, Inc.
- Florida Pharmaceutical Products, LLC
- 7-Eleven
- BI-MART
- Meijer Distribution, Inc.
- Dr. Reddy's Laboratories Inc.
- AAFES/Your Military Exchanges
- DISCOUNT DRUG MART, INC.
- McKesson Medical-Surgical
- OPMX LLC
- PUBLIX SUPER MARKETS INC
- Medline industries, LP
- Vivunt Pharma LLC
- Whole Foods Market, INC.
- Care One (Retail Business Services, LLC.)
- New World Imports
- Kesin Pharma Corporation
- SPIRIT PHARMACEUTICALS LLC
- Wal-Mart Stores, Inc
- CVS PHARMACY, INC.
- Cardinal Health (Leader) 70000
- Reliable 1 Laboratories LLC
- Jones Healthcare Group - Packaging Services, Inc
- Granules USA, Inc.
- HealthLife of USA LLC
- CARDINAL HEALTH
- Better Living Brands LLC
- DOLGENCORP, INC.
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product_type:
- HUMAN OTC DRUG
- HUMAN PRESCRIPTION DRUG
route:
- ORAL
- INTRAVENOUS
substance_name:
- IBUPROFEN
rxcui:
- '310964'
- '310965'
- '197803'
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nui:
- N0000000160
- M0001335
- N0000175722
pharm_class_moa:
- Cyclooxygenase Inhibitors [MoA]
pharm_class_cs:
- Anti-Inflammatory Agents, Non-Steroidal [CS]
pharm_class_epc:
- Nonsteroidal Anti-inflammatory Drug [EPC]
unii:
- WK2XYI10QM
- safetyreportversion: '1'
safetyreportid: '10003302'
primarysourcecountry: US
occurcountry: US
transmissiondateformat: '102'
transmissiondate: '20141002'
reporttype: '1'
serious: '2'
receivedateformat: '102'
receivedate: '20140312'
receiptdateformat: '102'
receiptdate: '20140312'
fulfillexpeditecriteria: '2'
companynumb: US-PFIZER INC-2014068976
duplicate: '1'
reportduplicate:
duplicatesource: PFIZER
duplicatenumb: US-PFIZER INC-2014068976
primarysource:
reportercountry: US
qualification: '5'
sender:
sendertype: '2'
senderorganization: FDA-Public Use
receiver:
receivertype: '6'
receiverorganization: FDA
patient:
patientsex: '1'
reaction:
- reactionmeddraversionpt: '17.0'
reactionmeddrapt: Drug ineffective
reactionoutcome: '6'
drug:
- drugcharacterization: '1'
medicinalproduct: LYRICA
drugauthorizationnumb: '021446'
drugdosagetext: UNK
actiondrug: '5'
openfda:
application_number:
- NDA021446
- NDA022488
brand_name:
- LYRICA
generic_name:
- PREGABALIN
manufacturer_name:
- Parke-Davis Div of Pfizer Inc
- Viatris Specialty LLC
product_ndc:
- 0071-1018
- 0071-1012
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- 0071-1014
- 0071-1015
- 0071-1016
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- 58151-238
- 58151-239
- 58151-240
- 58151-241
- 58151-243
- 58151-242
- 58151-244
product_type:
- HUMAN PRESCRIPTION DRUG
route:
- ORAL
substance_name:
- PREGABALIN
rxcui:
- '483438'
- '483440'
- '483442'
- '483444'
- '483446'
- '483448'
- '483450'
- '577127'
- '607018'
- '607020'
- '607022'
- '607024'
- '607026'
- '607028'
- '607033'
- '607038'
- '898715'
- '898718'
spl_id:
- e7c79058-03ba-4e7f-9a31-9ec5ce245161
- 1c2af07d-faf4-4fc7-b724-c5166746956d
spl_set_id:
- 60185c88-ecfd-46f9-adb9-b97c6b00a553
- d4734e7d-5079-455e-8ff5-8f4539c998a9
package_ndc:
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unii:
- 55JG375S6M
- safetyreportversion: '2'
safetyreportid: '10003304'
primarysourcecountry: US
occurcountry: US
transmissiondateformat: '102'
transmissiondate: '20141212'
reporttype: '1'
serious: '2'
receivedateformat: '102'
receivedate: '20140312'
receiptdateformat: '102'
receiptdate: '20140424'
fulfillexpeditecriteria: '2'
companynumb: US-PFIZER INC-2014063856
duplicate: '1'
reportduplicate:
duplicatesource: PFIZER
duplicatenumb: US-PFIZER INC-2014063856
primarysource:
reportercountry: US
qualification: '1'
sender:
sendertype: '2'
senderorganization: FDA-Public Use
receiver:
receivertype: '6'
receiverorganization: FDA
patient:
patientsex: '2'
reaction:
- reactionmeddraversionpt: '17.0'
reactionmeddrapt: Drug hypersensitivity
reactionoutcome: '6'
drug:
- drugcharacterization: '1'
medicinalproduct: DOXYCYCLINE HYCLATE
drugauthorizationnumb: '050007'
drugdosagetext: UNK
actiondrug: '5'
openfda:
application_number:
- ANDA062269
- ANDA062538
- ANDA062421
- ANDA211418
- ANDA065277
- ANDA207558
- ANDA213075
- ANDA211584
- NDA205931
- NDA208253
- ANDA210664
- ANDA062505
- ANDA062500
- ANDA211744
- ANDA210527
- ANDA211343
- ANDA065182
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- ANDA207774
- ANDA207773
- ANDA217685
- ANDA200856
- ANDA062396
- ANDA210537
- ANDA090134
- ANDA207289
- ANDA211012
- ANDA065095
- ANDA207494
- ANDA210536
- ANDA208818
- NDA050795
- ANDA065287
- ANDA212610
- ANDA062676
- ANDA062677
- ANDA065134
brand_name:
- DOXYCYCLINE HYCLATE
- DOXYCYCLINE
- TARGADOX
- DOXYCYCLINE HYCLATE DELAYED RELEASE
- ACTICLATE CAP
- DORYX MPC
generic_name:
- DOXYCYCLINE HYCLATE
- DOXYCYCLINE
- DOXYCLYCLINE HYCLATE
manufacturer_name:
- Epic Pharma, LLC
- Strides Pharma Science Limited
- Actavis Pharma, Inc.
- Macleods Pharmaceuticals Limited
- Chartwell RX, LLC
- Lupin Pharmaceuticals,Inc.
- JG Pharma Inc.
- Alembic Pharmaceuticals Limited
- Ajanta Pharma USA Inc.
- Novel Laboratories, Inc.
- Acella Pharmaceuticals, LLC
- Chartwell Governmental & Specialty RX, LLC
- Alembic Pharmaceuticals Inc.
- Cranbury Pharmaceuticals, LLC
- Chartwell RX LLC
- PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
- EPIC PHARMA, LLC
- Journey Medical Corporation
- Viona Pharmaceuticals Inc
- Slate Run Pharmaceuticals, LLC
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Hikma Pharmaceuticals USA Inc.
- Amneal Pharmaceuticals NY LLC
- Aqua Pharmaceuticals
- Solco Healthcare US LLC
- Lupin Pharmaceuticals, Inc.
- Zydus Lifesciences Limited
- Mayne Pharma Commercial LLC
- Larken Laboratories, Inc.
- Zhejiang Yongtai Pharmaceutical Co., Ltd
- Sun Pharmaceutical Industries, Inc.
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substance_name:
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nui:
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pharm_class_epc:
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pharm_class_cs:
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- Tetracyclines [CS]
- drugcharacterization: '1'
medicinalproduct: TRAMADOL HYDROCHLORIDE
drugdosagetext: UNK
drugdosageform: TABLET
actiondrug: '5'
openfda:
application_number:
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- ANDA200503
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- ANDA075977
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- ANDA201384
- ANDA075968
- ANDA202075
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brand_name:
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- TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE
- CONZIP
generic_name:
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manufacturer_name:
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- Lupin Pharmaceuticals, Inc.
- Trigen Laboratories, LLC
- Advagen Pharma Limited
- Teva Pharmaceuticals USA, Inc.
- Sun Pharmaceutical Industries, Inc.
- Unichem Pharmaceuticals (USA), Inc.
- Rising Pharma Holdings, Inc.
- Strides Pharma Science Limited
- Amneal Pharmaceuticals NY LLC
- Macleods Pharmaceuticals Limited
- TRUPHARMA LLC
- Aurobindo Pharma Limited
- Cranbury Pharmaceuticals, LLC
- TruPharma, LLC
- Vertical Pharmaceuticals, LLC
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product_type:
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route:
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- 13811-689-30
- 13811-690-30
- 13811-691-30
- 72888-162-30
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- 72888-162-00
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- 72888-080-05
- 72888-080-00
- 72888-163-30
- 72888-163-01
- 72888-163-05
- 72888-163-00
- 72888-008-01
- 72888-008-05
- 72888-008-00
- 0093-3301-01
- 0093-3301-05
- 47335-531-83
- 47335-531-88
- 47335-531-08
- 47335-531-18
- 47335-533-83
- 47335-533-88
- 47335-533-08
- 47335-533-18
- 47335-537-83
- 47335-537-88
- 47335-537-08
- 47335-537-18
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- 29300-355-05
- 29300-355-10
- 47335-859-83
- 47335-859-88
- 47335-859-08
- 47335-859-18
- 47335-860-83
- 47335-860-88
- 47335-860-08
- 47335-860-18
- 47335-861-83
- 47335-861-88
- 47335-861-08
- 47335-861-18
- 64980-614-01
- 64980-614-50
- 64980-614-10
- 64980-663-01
- 64380-791-01
- 64380-791-02
- 64380-791-03
- 64380-778-01
- 69238-2348-4
- 69238-2348-1
- 69238-2348-5
- 69238-2348-7
- 33342-269-07
- 33342-269-10
- 33342-269-11
- 33342-270-07
- 33342-270-10
- 33342-270-11
- 33342-271-07
- 33342-271-10
- 33342-271-11
- 52817-195-10
- 52817-195-50
- 52817-195-00
- 52817-196-10
- 52817-196-50
- 52817-196-00
- 59651-441-01
- 59651-441-05
- 59651-441-99
- 68180-697-06
- 68180-697-01
- 68180-697-02
- 68180-698-06
- 68180-698-01
- 68180-698-02
- 68180-699-06
- 68180-699-01
- 27808-301-01
- 27808-301-02
- 27808-301-03
- 52817-615-16
- 16571-716-01
- 16571-716-50
- 16571-716-10
- 68025-071-30
- 68025-072-30
- 68025-073-30
unii:
- 9N7R477WCK
- drugcharacterization: '1'
medicinalproduct: OXYCONTIN
drugdosagetext: UNK
actiondrug: '5'
openfda:
application_number:
- NDA022272
brand_name:
- OXYCONTIN
generic_name:
- OXYCODONE HYDROCHLORIDE
manufacturer_name:
- Knoa Pharma LLC
product_ndc:
- 59011-410
- 59011-415
- 59011-420
- 59011-430
- 59011-440
- 59011-460
- 59011-480
product_type:
- HUMAN PRESCRIPTION DRUG
route:
- ORAL
substance_name:
- OXYCODONE HYDROCHLORIDE
rxcui:
- '1049504'
- '1049545'
- '1049565'
- '1049576'
- '1049586'
- '1049595'
- '1049601'
- '1860127'
- '1860129'
- '1860137'
- '1860148'
- '1860151'
- '1860154'
- '1860157'
spl_id:
- 47b30347-ae1d-4b54-8ccd-594eb7bdbd75
spl_set_id:
- bfdfe235-d717-4855-a3c8-a13d26dadede
package_ndc:
- 59011-410-10
- 59011-410-20
- 59011-415-10
- 59011-415-20
- 59011-420-10
- 59011-420-20
- 59011-430-10
- 59011-430-20
- 59011-440-10
- 59011-440-20
- 59011-460-10
- 59011-460-20
- 59011-480-20
- 59011-480-10
unii:
- C1ENJ2TE6C
- drugcharacterization: '1'
medicinalproduct: TALWIN
drugdosagetext: UNK
actiondrug: '5'
- drugcharacterization: '1'
medicinalproduct: CODEINE
drugdosagetext: UNK
actiondrug: '5'
- drugcharacterization: '1'
medicinalproduct: IODINE
drugdosagetext: UNK
actiondrug: '5'
openfda:
application_number:
- M003
brand_name:
- IODINE
- IODIUM
- IODDO IODINE
generic_name:
- IODINE
manufacturer_name:
- United Natural Foods, Inc. dba UNFI
- Boiron
- Walgreen Co.
- EVI LABS
- Nice-Pak Products, LLC
product_ndc:
- 41163-088
- 0220-2656
- 0220-2673
- 0220-2664
- 0220-2659
- 0220-2657
- 0220-2674
- 0363-0088
- 84178-005
- 0220-2661
- 11344-880
product_type:
- HUMAN OTC DRUG
route:
- TOPICAL
- ORAL
substance_name:
- IODINE
rxcui:
- '311093'
spl_id:
- 4af729f3-e20c-e7e0-e063-6294a90aca80
- f187ae44-71c0-a682-e053-2995a90a6426
- 0a0d95f0-5c70-6afd-e063-6394a90a6ae6
- 0a0d95f0-5c6e-6afd-e063-6394a90a6ae6
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- f2f38dd9-20d5-8a84-e053-2a95a90a7ed2
- 4cd627b7-4d2d-0a03-e063-6294a90ae4f7
spl_set_id:
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- 4af8552c-1f2b-84ad-e063-6394a90abb62
- 85cd5e7a-52a7-0bb7-e053-2a91aa0aaa14
- 857f13fe-51c9-4e5b-b5e2-a981dedabf71
package_ndc:
- 41163-088-10
- 0220-2656-41
- 0220-2673-41
- 0220-2664-41
- 0220-2659-41
- 0220-2657-41
- 0220-2674-41
- 0363-0088-10
- 84178-005-03
- 0220-2661-41
- 11344-880-10
unii:
- 9679TC07X4
- drugcharacterization: '1'
medicinalproduct: ASPIRIN
drugdosagetext: UNK
actiondrug: '5'
openfda:
application_number:
- M013
- M013.50
- part343
- M
brand_name:
- BAYER GENUINE ASPIRIN
- ASPIRIN
- ENTERIC ASPIRIN
- ADULT LOW DOSE ASPIRIN
- CHEWABLE ASPIRIN
- DRUG MART EFFERVESCENT PAIN RELIEF
- ASPIRIN LOW DOSE
- ASPIRIN ENTERIC COATED
- ASPIRIN 81
- ADULT CHEWABLE ASPIRIN
- ASPIRIN 81MG
- ADULT LOW DOSE ENTERIC COATED ASPIRIN
- ASPIRIN LOW DOSE SAFETY COATED
- GERITREX ASPIRIN
- BUFFERED ASPIRIN
- ENTERIC COATED ASPIRIN
- BUFFERIN REGULAR STRENGTH PAIN RELIEF
- WISPIRIN
- EQUATE ASPIRIN
- LOW DOSE ASPIRIN
- HEB EFFERVESCENT PAIN RELIEF
- PAIN RELIEF ASPIRIN LOW DOSE
- ASPIRIN 81 MG LOW DOSE
- ASPIRIN EXTRA STRENGTH
- BAYER CHEWABLE - ASPIRIN REGIMEN LOW DOSE ASPIRIN CHERRY FLAVORED
- TRAVEL SAVVY ASPIRIN
- CHEWABLE ASPIRIN 81 MG
- TOPCARE ASPIRIN
- RAPIDOL ASPIRIN
- CAREALL ASPIRIN
- ASPIRIN REGULAR STRENGTH
- REGULAR STRENGTH ASPIRIN
- LOW DOSE MINIPRIN ENTERIC SAFETY COATED
- ASPIRIN DELAYED RELEASE
- GOOD NEIGHBOR PHARMACY ASPIRIN
- LEADER ASPIRIN
- CHEWABLE LOW DOSE ASPIRIN
- CIRCLE K ASPIRIN 325
- LOW DOSE ASPIRIN ENTERIC SAFETY COATED
- ASPIRIN 81MG ENTERIC COATED
- CHILDRENS ASPIRIN
- CVS EFFERVESCENT PAIN RELIEVER
- BASIC CARE ASPIRIN
- SIGNATURE SELECT EFFERVESCENT PAIN RELIEF
- ASPIRIN ENTERIC COATED, REGULAR STRENGTH
- ASPIRIN LOW DOSE CHEWABLE
- ASPIRIN ENTERIC SAFETY COATED
- ASPIRIN 325 MG
- MEDIQUE AT HOME ASPIRIN
- REGULAR STRENGTH ENTERIC COATED ASPIRIN
- DYE-FREE ASPIRIN 81
- PUBLIX FAST RELIEF EFFERVESCENT - ORIGINAL FLAVOR
- BEST CHOICE EFFERVESCENT PAIN RELIEVER 36
- ASPIRIN 81 MG
- BAYER ASPIRIN ORIGINAL, TRAVEL BASIX
- BAYER ASPIRIN ORIGINAL, CVP HEALTH
- BAYER
- QUALITY CHOICE EFFERVESCENT PAIN RELIEF
- MEDLINE
- ASPI-COR
- UNISHIELD ASPIRIN
- FAMILY WELLNESS PAIN RELIEVER
- ASPIRINA CAPLETS
- ASPIRIN 81MG ENTERIC COATED LOW STRENGTH ASPIRIN REGIMEN
- EQUATE ASPIRIN CHEWABLE
- GOOD SENSE ASPIRIN
- BAYER ASPIRIN REGIMEN ENTERIC COATED
- RUGBY ASPIRIN
- ASPIRIN NSAID
- RIGHT REMEDIES LOW DOSE ASPIRIN 81MG
- ASPIRIN 50 CT
- SUNMARK ASPIRIN
- ASPIRIN PAIN RELIEF
- DIRECT SAFETY ASPIRIN
- ASPIRIN 81MG ENTERIC COATED DELAYED RELEASE
- FIRST AID DIRECT CHEWABLE ASPIRIN
- FOSTER AND THRIVE ASPIRIN
- ADULT LOW DOSE CHEWABLE ASPIRIN
- ENTERIC COATED ASPIRIN REGULAR STRENGTH
- LIL DRUG STORE ASPIRIN 325
- DOLLAR GENERAL EFFERVESCENT PAIN RELIEVER
- ASPIRIN CHEWABLE, LOW DOSE
- ASPIRIN LOW DOSE CHEWABLE ORANGE
- ADULT LOW DOSE PAIN RELIEVER
- ASPIRIN PAIN RELIVER
- DG HEALTH ASPIRIN
- LOW DOSE CHEWABLE ASPIRIN
- ASPIRIN REGIMEN
- GREEN GUARD CHEWABLE ASPIRIN 81 MG
- ECOTRIN REGULAR STRENGTH
- GENCARE-ASPIRIN LOW DOSE PAIN RELIEVER (NSAID)
- ASPIRIN LOW DOSE ENTERIC COATED
- PHYSICIANS CARE ASPIRIN
- ASPIRIN 325
- BAYER LOW DOSE
- MARKET BASKET EFFERVESCENT PAIN RELIEF
- BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE
- WINCO FOODS EFFERVESCENT PAIN RELIEF
- MEIJER LOW DOSE ASPIRIN
- ASPIRIN LOW STRENGTH
- LOW STRENGTH CHEWABLE ASPIRIN
- MEDIQUE PRODUCTS CHEWABLE LOW DOSE ASPIRIN
- PAIN RELIEF ASPIRIN CHEWABLE, LOW DOSE
- ASPIRIN 81MG ADULT LOW DOSE
- ECOTRIN
- EXTRA STRENGTH ASPIRIN
- LOW DOSE ASPIRIN 81MG
- NOBLEAID PAIN RELIEVER
- COATED ASPIRIN
- TOPCARE EFFERVESCENT PAIN RELIEF
- ASPIRIN 325 MG EC
- XPECT CHEWABLE ASPIRIN
- MCKESSON ASPIRIN
- GOOD SENSE EFFERVESCENT PAIN RELIEF
- MEIJER EFFERVESCENT PAIN RELIEF
- ASPIRIN CHEWABLE
- PAIN RELIEF ASPIRIN
- REGULAR STRENGTH ASPIRIN 325 MG
- ST. JOSEPH LOW DOSE ASPIRIN
- CARDIASPIRIN PROTECT
- ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN
- MEDIQUE PRODUCTS ASPIRIN
- MEDI-FIRST ASPIRIN
- MEDI-FIRST PLUS ASPIRIN
- EQUALINE EFFERVESCENT PAIN RELIEVER
- ASPIRIN ENTERIC COATED LOW DOSE
- ADULT LOW STRENGTH ASPIRIN
- THOMPSON ASPIRIN
- LOW DOSE ASPIRIUN
- ULINE ASPIRIN
generic_name:
- ASPIRIN
- ASPIRIN 81 MG
- ASPIRIN 325 MG
manufacturer_name:
- Unifirst First Aid Corporation
- Health Pharma USA LLC
- Topco Associates, LLC
- Walgreen Company
- CHAIN DRUG MARKETING ASSOCIATION INC
- Advanced Rx LLC
- Chain Drug Marketing Association, Inc.
- Discount Drug Mart Inc
- STRATEGIC SOURCING SERVICES LLC
- L.N.K. International, Inc.
- Grocery Outlet
- Rising Pharma Holdings, Inc.
- HARRIS TEETER
- BETTER LIVING BRANDS LLC.
- Bi-Mart
- Trifecta Pharmaceuticals USA LLC
- Marc Glassman, Inc.
- Care One (Retail Business Services, LLC.)
- Geritrex LLC
- Cardinal Health 110, LLC. DBA Leader
- DISCOUNT DRUG MART
- Genomma Lab USA
- Wisdrug AG
- Wal-Mart Stores Inc
- Advance Pharmaceutical Inc.
- P & L Development, LLC
- H. E. BUTT GROCERY COMPANY
- Rite Aid Corporation
- Richmond Pharmaceuticals, Inc.
- Magno-Humphries, Inc.
- CHAIN DRUG MARKETING ASSOCIATION, INC.
- Time-Cap Labs, Inc
- Bayer HealthCare LLC.
- Allegiant Health
- Amerisource Bergen
- Bellegrove Medical Supply, Inc.
- Padagis US LLC
- United Natural Foods, Inc. dba UNFI
- PROSTAT FIRST AID
- HYVEE INC
- Topco Associates LLC
- COSTCO WHOLESALE CORPORATION
- Geri-Care Pharmaceutical Corp
- Pharmadel LLC
- Better Living Brands LLC
- New World Imports, Inc
- MAJOR PHARMACEUTICALS
- Publix Super Markets Inc
- CARDINAL HEALTH, INC.
- FOODHOLD U.S.A., LLC
- Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- VALU MERCHANDISERS COMPANY
- Geiss, Destin & Dunn Inc.
- MARC GLASSMAN, INC.
- Cardinal Health 110, LLC. dba Leader
- ARMY AND AIR FORCE EXCHANGE SERVICE
- TARGET CORPORATION
- Meijer Distribution, Inc.
- RMT HEALTH LLC
- Lil Drug Store Products, Inc
- DOLGENCORP, LLC
- Cardinal Health 107, LLC
- HART Health
- CVS PHARMACY
- Amazon.com Services LLC
- Safeway Inc.
- AAA Pharmaceutical, Inc.
- Better Living Brands, LLC
- Publix Supermarkets, Inc.
- Hi-Tech Nutraceuticals, LLC
- WALGREENS
- PUBLIX SUPER MARKETS INC.
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Lil' Drug Store Products, Inc.
- RETAIL BUSINESS SERVICES , LLC.
- SAM'S WEST INC
- BJWC (Berkley & Jensen / BJ's)
- Medline Industries, LP
- Unishield
- Valu Merchandisers Company
- Chain Drug Marketing Association
- Lidl US LLC
- Akron Pharma Inc.
- FAMILY WELLNESS SERVICES, INC.
- Kroger Company
- Topco Associates
- CVS Pharmacy
- L. Perrigo Company
- Rugby Laboratories
- Gendose Pharmaceuticals, LLC
- Hy-Vee
- Reliable 1 Laboratories LLC
- TOP CARE (Topco Associates LLC)
- TIME CAP LABORATORIES, INC
- Strive Pharmaceuticals Inc.
- HyVee Inc
- Strategic Sourcing Services LLC
- BETTER LIVING BRANDS, LLC
- JHK Inc dba American Safety & First Aid
- Meijer
- Direct Safety
- Salado Sales, Inc.
- Cintas Corp
- Farmacias De Similares TX LLC
- Geri-Care Pharmaceuticals, Corp
- Family Dollar Services Inc
- Dolgencorp, Inc
- Major Pharmaceuticals
- Pinnacle RX LLC
- GOODSENSE
- Health Pharma USA, LLC
- TWIN MED LLC
- Pioneer Life Sciences, LLC
- Meijer Distribution Inc
- H E B
- Dolgencorp, LLC
- Marlex Pharmaceuticals Inc.
- Sam's West Inc
- WinCo Foods, LLC
- Unifirst First Aid Corporaiton
- Safeway
- Medtech Products Inc.
- Lodaat LLC
- Acme United Corporation
- McKesson Medical-Surgical, Inc.
- DEMOULAS SUPER MARKETS, INC.
- Winco Foods, LLC
- Meijer, Inc.
- Richmond Pharmaceuticals, Inc
- Famora Inc.
- PUBLIX SUPER MARKETS INC
- FSA STORE INC.
- Pharbest Pharmaceuticals, Inc.
- Discount Drug Mart
- Dr. Wayne's
- H-E-B
- TopCare
- HHH Pharmaceuticals
- Athlete's Needs Inc
- Noble Otc LLC
- TOPCO ASSOCIATES LLC
- Cintas Corporation
- McKesson Medical-Surgical
- AMERIFOODS TRADING COMPANY
- TIME CAP LABS INC
- Perrigo Direct, Inc.
- Walmart Inc.
- Kroger
- HEB
- AmerisourceBergen (Good Neighbor Pharmacy) 46122
- Foundation Consumer Healthcare
- Aarkish Pharmaceuticals NJ Inc.
- OPMX LLC
- Foundation Consumer Healthcare LLC
- INVAHEALTH INC
- UNITED NATURAL FOODS, INC. DBA UNFI
- NUVICARE LLC
- Thompson
- FSA Store Inc.
- ULINE
- Wildman Business Group
product_ndc:
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- 71679-302
- 36800-545
- 0363-0587
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- 0363-0563
- 16103-366
- 79481-6450
- 84324-017
- 63868-373
- 53943-146
- 73408-618
- 73408-620
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- 46122-596
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- 83586-104
- 11673-188
- 51824-057
- 81522-018
- 61504-105
- 69790-616
- 69790-620
- 0363-6450
- 53943-152
- 84269-2501
product_type:
- HUMAN OTC DRUG
route:
- ORAL
- RECTAL
substance_name:
- ASPIRIN
rxcui:
- '211874'
- '212033'
- '308416'
- '198467'
- '318272'
- '2606079'
- '260847'
- '198471'
- '825180'
- '198464'
- '1052678'
- '1600991'
- '387090'
- '212086'
- '794229'
- '1189781'
- '243670'
- '749795'
- '211832'
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nui:
- N0000000160
- N0000008836
- M0001335
- N0000175722
- N0000175578
- N0000008832
pharm_class_moa:
- Cyclooxygenase Inhibitors [MoA]
pharm_class_pe:
- Decreased Prostaglandin Production [PE]
- Decreased Platelet Aggregation [PE]
pharm_class_cs:
- Anti-Inflammatory Agents, Non-Steroidal [CS]
pharm_class_epc:
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Platelet Aggregation Inhibitor [EPC]
unii:
- R16CO5Y76E
- drugcharacterization: '1'
medicinalproduct: LORTAB
drugdosagetext: UNK
actiondrug: '5'
- drugcharacterization: '1'
medicinalproduct: FIORINAL
drugdosagetext: UNK
actiondrug: '5'
parser_errors:
- 'Partial response: 100 of 20692690 provider records'
logical_asset_id: 2a8fd49185adba219af524bd
related_dataset_ids: []
quality:
score: 60
parsing_errors:
- 'Partial response: 100 of 20692690 provider records'
- 'Partial response: 100 of 20692690 provider records'
stale_warning: null
broken_source_report: null
rss_feed_url: null
odc_version: '0.1'
last_successful_scan_at: '2026-09-26T19:12:57+00:00'
Revision dbt Source YAML
version: 2
sources:
- name: fda_drug_adverse_events
description: FDA Drug Adverse Event Reports Sample discovered from api.fda.gov.
Bounded source query (limit=100); completeness is not assumed.
meta:
opendataodc:
dataset_id: fda-drug-adverse-events
revision_id: 20260926191257-e93d4b3eac5e
detected_at: '2026-09-26T19:12:57+00:00'
source_url: https://api.fda.gov/drug/event.json?limit=100
tables:
- name: event_json
description: Source asset event.json.
meta:
opendataodc:
source_url: https://api.fda.gov/drug/event.json?limit=100
content_hash: 585f3120b49f21d06370906a2dc7bf10bd513dda8c40605d36458e1c56ca5dcf
row_count: 100
parser_errors:
- 'Partial response: 100 of 20692690 provider records'
columns:
- name: companynumb
- name: duplicate
- name: fulfillexpeditecriteria
- name: occurcountry
- name: patient
- name: primarysource
- name: primarysourcecountry
- name: receiptdate
- name: receiptdateformat
- name: receivedate
- name: receivedateformat
- name: receiver
- name: reportduplicate
- name: reporttype
- name: safetyreportid
- name: safetyreportversion
- name: sender
- name: serious
- name: seriousnessdeath
- name: seriousnessdisabling
- name: seriousnesshospitalization
- name: seriousnesslifethreatening
- name: seriousnessother
- name: transmissiondate
- name: transmissiondateformat
Sample Rows
companynumb | duplicate | fulfillexpeditecriteria | occurcountry | patient | primarysource | primarysourcecountry | receiptdate | receiptdateformat | receivedate | receivedateformat | receiver | reportduplicate | reporttype | safetyreportid | safetyreportversion | sender | serious | seriousnessdeath | seriousnessdisabling | seriousnesshospitalization | seriousnesslifethreatening | seriousnessother | transmissiondate | transmissiondateformat |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
JACAN16471 | Empty | 1 | Empty | {"patientonsetage": "26", "patientonsetageunit": "801", "patientsex": "1", "patientdeath": {"patientdeathdateformat": null, "patientdeathdate": null}, "reaction": [{"reactionmeddrapt": "DRUG ADMINISTRATION ERROR"}, {"reactionmeddrapt": "OVERDOSE"}], "drug": [{"drugcharacterization": "1", "medicinalproduct": "DURAGESIC-100", "drugauthorizationnumb": "019813", "drugadministrationroute": "041", "drugindication": "DRUG ABUSE"}]} | {"reportercountry": "CANADA", "qualification": "3"} | Empty | 20080625 | 102 | 20080707 | 102 | Null | Empty | Empty | 5801206-7 | Empty | {"senderorganization": "FDA-Public Use"} | 1 | 1 | Empty | Empty | Empty | Empty | 20090109 | 102 |
1289378 | 1 | 2 | Empty | {"patientonsetage": "77", "patientonsetageunit": "801", "patientsex": "2", "reaction": [{"reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Vomiting"}, {"reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Diarrhoea"}, {"reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Arthralgia"}, {"reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Headache"}], "drug": [{"drugcharacterization": "1", "medicinalproduct": "BONIVA", "drugbatchnumb": "H6200HO3", "drugauthorizationnumb": "021858", "drugstructuredosagenumb": "3", "drugstructuredosageunit": "003", "drugdosagetext": "3 MG, 1 IN 3 M, INTRAVENOUS (NOT OTHERWISE SPECIFIED)", "drugadministrationroute": "042", "drugindication": "OSTEOPOROSIS", "drugstartdateformat": "102", "drugstartdate": "20130913"}]} | {"reportercountry": "US", "qualification": "5"} | US | 20140306 | 102 | 20140306 | 102 | {"receivertype": "6", "receiverorganization": "FDA"} | {"duplicatesource": "GENENTECH", "duplicatenumb": "1289378"} | 1 | 10003300 | 1 | {"sendertype": "2", "senderorganization": "FDA-Public Use"} | 1 | Empty | 1 | Empty | Empty | Empty | 20141002 | 102 |
US-JNJFOC-20130719067 | 1 | 2 | Empty | {"patientsex": "2", "reaction": [{"reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dyspepsia"}, {"reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Renal impairment"}], "drug": [{"drugcharacterization": "1", "medicinalproduct": "IBUPROFEN", "drugauthorizationnumb": "17463", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "drugadditional": "3", "openfda": {"application_number": ["ANDA078682", "ANDA077349", "505G(a)(3)", "ANDA079174", "ANDA074937", "ANDA210602", "ANDA202312", "ANDA075217", "ANDA091355", "ANDA075010", "ANDA076359", "ANDA209179", "ANDA210755", "NDA020944", "ANDA091239", "ANDA075682", "NDA020589", "ANDA202413", "ANDA091237", "NDA020516", "ANDA210149", "ANDA072096", "ANDA207095", "ANDA220239", "ANDA206568", "ANDA217261", "ANDA204469", "ANDA207753", "ANDA079233", "ANDA079205", "ANDA206999", "ANDA075139", "NDA020402", "ANDA091625", "ANDA213794", "NDA022348", "ANDA079129", "ANDA215318", "ANDA208865", "M", "ANDA078329", "ANDA078558", "ANDA209204", "ANDA214789", "NDA018989", "ANDA071268", "ANDA074916", "ANDA071333", "NDA020603", "ANDA076460", "ANDA202300", "ANDA209207", "ANDA203599", "ANDA215311", "ANDA071334", "ANDA209178", "ANDA071935", "M013", "ANDA079058", "ANDA072199", "NDA020812", "ANDA071265", "ANDA090796", "ANDA071335", "ANDA211666", "ANDA215777", "ANDA074978", "ANDA076925", "NDA020267", "M012", "ANDA213506"], "brand_name": ["IBUPROFEN", "CAREONE IBUPROFEN", "GOOD REMEDIES IBUPROFEN 200 MG", "IBUPROFEN CHILDRENS", "CHILDRENS IBUPROFEN ORAL SUSPENSION, DYE FREE", "INFANTS DYE FREE IBUPROFEN", "LEADER CHILDRENS IBUPROFEN", "GOOD SENSE CHILDRENS IBUPROFEN", "CABINET PAIN RELIEVER AND FEVER REDUCER", "CHILDRENS IBUPROFEN", "CONCENTRATED IBUPROFEN INFANTS", "JUNIOR STRENGTH ADVIL", "IBU", "MEDIQUE IPRIN", "MEDI-FIRST IBUPROFEN", "MEDI-FIRST PLUS IBUPROFEN", "DOVER ADDAPRIN", "GREEN GUARD IBUPRO RELIEF", "CHILDRENS ADVIL", "CARE ONE IBUPROFEN CHILDRENS", "CHILDRENS MOTRIN", "CHILDRENS IBUPROFEN ORAL SUSPENSION DYE FREE", "ULINE IBUPROFEN", "GOOD NEIGHBOR PHARMACY IBUPROFEN", "UP AND UP CHILDRENS IBUPROFEN", "DYE FREE CHILDRENS IBUPROFEN", "BASIC CARE IBUPROFEN", "XPECT IBUPROFEN", "IBUPROFEN INFANTS", "IBUPROFEN MINIS", "KOSHER MEDS", "EQUATE IBUPROFEN", "FOSTER AND THRIVE CHILDRENS IBUPROFEN IB", "DYE-FREE PAIN RELIEF", "IBUPROFEN MINI DYE FREE", "DOLEX FLEX", "IBUPAK", "DYE FREE IBUPROFEN", "ADVIL LIQUI-GELS", "BETR PAIN RELIEF", "EQUALINE CHILDRENS IBUPROFEN", "CHILDRENS IBUPROFEN BUBBLEGUM", "CHILDRENS IBUPROFEN FRUIT", "CHILDRENS IBUPROFEN BLUE RASPBERRY", "CHILDRENS IBUPROFEN GRAPE", "IBUPROFEN IB", "KOSHER MEDS DYE-FREE IBUPROFEN", "TOPCARE CHILDRENS IBUPROFEN", "REXALL IBUPROFEN", "ADVIL MIGRAINE", "IBUPROFEN 200MG", "DG HEALTH IBUPROFEN", "CALDOLOR", "EQUATE IBUPROFEN CHILDRENS", "GOOD NEIGHBOR PHARMACY CHILDRENS IBUPROFEN", "BERKLEY AND JENSEN IBUPROFEN", "EQUALINE IBUPROFEN", "HENRY SCHEIN IBUPROFEN", "PROFEN IB INFANTS", "IBUPROFEN MIGRAINE", "ASSURED IBUPROFEN", "UP AND UP IBUPROFEN", "CAREONE CHILDRENS IBUPROFEN", "CHILDRENS IBUPROFEN ORAL SUSPENSION", "BASIC CARE CHILDRENS IBUPROFEN", "PROFEN IB CHILDRENS", "BASIC CARE INFANTS IBUPROFEN", "ADVIL", "EQUALINE IBUPROFEN CHILDRENS", "FOSTER AND THRIVE IBUPROFEN", "IBUPROFEN PAIN RELEIVER/ FEVER REDUCER", "IBUPROFEN 24/7 LIFE BY 7-ELEVEN", "LEADER IBUPROFEN", "GOOD SENSE IBUPROFEN CHILDRENS", "INFANTS MOTRIN", "IBUPROFEN THOMPSON", "DYE-FREE IBUPROFEN", "IBUPROFEN DYE FREE", "MOTRIN INFANTS", "IBUPROFEN PAIN RELIEVER/FEVER REDUCER", "PAIN RELIEF IBUPROFEN", "IBUPROFEN IMMEDIATE RELEASE", "PROFEN IB", "MOTRIN IB", "BETR REMEDIES IBUPROFEN", "CHILDRENS IBUPROFEN 572", "KIRKLAND SIGNATURE IBUPROFEN", "GOOD SENSE IBUPROFEN", "IBUPROFEN 200 MG", "CHILDRENS IBUPROFEN 100", "CHILDRENS FLANAX ORAL", "AMAZON BASIC CARE IBUPROFEN", "TOPCARE IBUPROFEN", "CHILDRENS IBUPROFEN ORAL SUSPENSION ORIGINAL BERRY FLAVOR", "UP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN", "COUNTERACT IB", "SIGNATURE CARE CHILDRENS IBUPROFEN", "PAIN RELIEF", "CHILDRENS IBUPROFEN BUBBLEGUM DYE FREE", "RIGHT REMEDIES IBUPROFEN 200 MG", "UNISHIELD IBUPROFEN", "IBUPROFEN CA", "DYE-FREE IBUPROFEN 200", "IBUPROFEN 100", "IBUPROFEN 250", "INFANTS IBUPROFEN", "IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER", "CARE ONE IBUPROFEN", "CHILDRENS IBUPROFEN ORAL SUSPENSION, BUBBLE GUM", "GREEN GUARD IBUPROFEN RELIEF", "KIRKLAND SIGNATURE IBUPROFEN IB", "PEDIACARE CHILDRENS IBUPROFEN BERRY", "GOOD SENSE IBUPROFEN INFANTS", "INFANTS ADVIL", "CIRCLE K IBUPROFEN", "IBUPROFEN INFANTS DROPS", "CVS IBUPROFEN", "SIGNATURE CARE IBUPROFEN", "PARENTS CHOICE INFANTS IBUPROFEN", "LEADER INFANTS IBUPROFEN", "GOOD NEIGHBOR PHARMACY IBUPROFEN CHILDRENS", "TOPCARE INFANTS IBUPROFEN", "GOODNOW PAIN RELIEF", "CHILDRENS IBUPROFEN 100 DYE FREE", "FLEX-PRIN", "PAIN RELIEF - IBUPROFEN 200 MG", "DIRECT SAFETY IBUPROFEN", "IBUPROFEN, LIL DRUG STORE", "MEDIQUE AT HOME IPRIN", "IBUPROFEN FAST RELIEF MEDICINE FOR PAIN", "MIGRAINE RELIEF", "LIL DRUG STORE IBUPROFEN", "MCKESSON IBUPROFEN 200 MG", "IBUWIN FORTE", "IBUPROFEN 200", "DG HEALTH CHILDRENS IBUPROFEN", "IBUPROFEN, CIRCLE K, 50CT", "IBUPROFEN, CASEYS, 50CT", "IBUPROFEN, LIL DRUG STORE, 50CT", "IBUPROFEN, LIL DRUG STORE, 24CT", "MOTRIN IB, TRAVEL BASIX", "MOTRIN IB, CVP HEALTH", "365 WHOLE FOODS MARKET IBUPROFEN", "CAREALL IBUPROFEN", "GOOD SENSE INFANTS IBUPROFEN", "VALUMEDS IBUPROFEN", "DOLEX CHILDREN", "IBUPROFEN DYE-FREE", "MOTRIN IB MIGRAINE", "FAST PAIN RELIEF", "FOSTER AND THRIVE INFANTS IBUPROFEN"], "generic_name": ["IBUPROFEN", "IBUPROFEN CAPSULES 200 MG", "IBUPROFEN TABLETS USP, 200MG", "IBUPROFEN TABLET, FILM COATED", "IBUPROFEN ORAL", "IBUPROFEN 200MG", "IBUPFROFEN", "IBUPROFEN TABLET, FILM-COATED", "IBUPROFEN 200 MG", "IBUPROFEN CAPSULE"], "manufacturer_name": ["DOLGENCORP INC", "American Sales Company", "Strive Pharmaceuticals Inc.", "Rite Aid Corporation", "Dolgencorp, Inc.", "HyVee Inc", "Best Choice", "Harris Teeter", "Kroger Company", "Cardinal Health 110, LLC. dba Leader", "PuraCap Pharmaceutical LLC", "NUVICARE LLC", "Geritrex LLC", "L. Perrigo Company", "Spirit Pharmaceutical LLC", "Meijer, Inc.", "TWIN MED LLC", "Better Living Brands, LLC", "Wal-Mart Stores, Inc.", "Haleon US Holdings LLC", "SAM'S WEST INC", "Dr. Reddy's Laboratories Limited", "Unifirst First Aid Corporation", "Chartwell RX, LLC", "CVS Pharmacy", "TIME CAP LABORATORIES,INC", "Kenvue Brands LLC", "Aurohealth LLC", "AptaPharma Inc.", "Chain Drug Marketing Association Inc.", "Uline", "Breeden Brothers, LLC", "FSA STORE INC.", "Shield Pharmaceuticals Corp", "Amerisource Bergen", "Target Corporation", "CVS", "Amazon.com Services LLC", "Advagen Pharma Ltd.", "WALGREEN COMPANY", "Cintas Corporation", "Sun Pharmaceutical Industries, Inc.", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "Mollec Inc", "INGLES MARKETS, INC.", "BJWC", "Pioneer Life Sciences, LLC", "Wal-Mart Stores Inc", "Strategic Sourcing Services LLC", "Bionpharma Inc.", "Grocery Outlet, Inc.", "Randob Labs., Ltd.", "CHAIN DRUG MARKETING ASSOCIATION INC.", "Amneal Pharmaceuticals of New York LLC", "Winco Foods, LLC", "Walgreens", "Pharmadel LLC", "RETAIL BUSINESS SERVICES , LLC.", "PureTek Corporation", "CHAIN DRUG MARKETING ASSOCIATION INC", "Lil Drug Store Products, Inc", "H E B", "Live Betr LLC", "Softgel Healthcare Private Limited", "United Natural Foods, Inc. dba UNFI", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "Granules India Limited", "Guardian Drug Company", "WINCO FOODS, LLC", "NorthStar Rx LLC", "Major Pharmaceuticals", "Topco Associates LLC", "Dolgencorp, LLC", "Allegiant Health", "Walgreen Company", "Care One (American Sales Company)", "L.N.K. International, Inc.", "Retail Business Services, LLC", "Geri-Care Pharmaceutical Corp", "Dolgencorp Inc", "Cumberland Pharmaceuticals Inc.", "GOODSENSE", "Family Dollar (FAMILY WELLNESS)", "Westminster Pharmaceuticals, LLC", "Chain Drug Marketing Association, Inc.", "VALU MERCHANDISERS COMPANY", "TIME CAP LABORATORIES, INC.", "Spirit Pharmaceuticals LLC", "WR Group, Inc.", "BETTER LIVING BRANDS, LLC", "Rugby Laboratories, Inc.", "HART Health", "Henry Schein Inc.", "MARKSANS PHARMA LIMITED", "Topco Associates, LLC", "WALGREENS", "Publix Super Markets Inc", "SOLA Pharmaceuticals, LLC", "Meijer Distribution Inc", "Best Choice (Valu Merchandisers Company)", "TOPCO ASSOCIATES LLC", "Trifecta Pharmaceuticals USA LLC", "AMERISOURCE BERGEN", "RITE AID", "PAI Holdings, LLC dba PAI Pharma", "TOP CARE (Topco Associates LLC)", "Marc Glassman, Inc.", "Chain Drug Consortium", "RITE AID CORPORATION", "HEB", "Amneal Pharmaceuticals LLC", "Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd", "Pharmaceutical Associates, Inc.", "Amneal Pharmaceuticals NY LLC", "KROGER COMPANY", "Lil' Drug Store Products, Inc.", "FSA Store Inc. (Caring Mills)", "PURACAP PHARMACEUTICAL LLC", "Thompson Safety", "FSA Store Inc. (Caring Mill)", "PLD Acquisitions LLC DBA Avma Pharma Solutions", "Cardinal Health 110, LLC. DBA Leader", "Lidl US LLC", "BluePoint Laboratories", "WALMART INC.", "BETTER LIVING BRANDS LLC.", "Sam's West, Inc", "MARC GLASSMAN, INC.", "Strides Pharma Inc", "Chalkboard Health", "TIME CAP LABORATORIES, INC", "Family Dollar Services, Inc.", "BJWC (Berkley & Jensen / BJ's)", "Costco Wholesale Company", "Safeway", "RETAIL BUSINESS SERVICES,LLC.", "Discount Drug Mart", "Basic Drugs, Inc.", "Padagis Israel Pharmaceuticals Ltd", "Strides Pharma Science Limited", "AiPing Pharmaceutical, Inc.", "DEMOULAS SUPERMARKETS INC.", "ARMY AND AIR FORCE EXCHANGE SERVICE", "Belmora LLC", "The Kroger Co.", "WALGREEN CO.", "Gobrands, Inc. (Goodnow)", "Puro Pharma Inc.", "Aurobindo Pharma Limited", "Melaleuca, Inc", "Costco Wholesale", "P & L Development, LLC", "Albertsons Companies", "Discount Drug Mart, Inc", "PROSTAT FIRST AID", "Wildman Business Group", "Unishield", "MEIJER DISTRIBUTION INC.", "Granules Pharmaceuticals Inc.", "TARGET CORPORATION", "Ascend Laboratories, LLC", "Safeway, Inc.", "CVS Pharmacy. Inc.", "Chain Drug Consortium, LLC", "JHK Inc dba American Safety & First Aid", "Harris Teeter, LLC", "Demoulas Super Markets, Inc", "ADVANCED FIRST AID, INC.", "Sam's West Inc", "Family Dollar Services Inc", "DISCOUNT DRUG MART", "Unifirst First Aid", "RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH", "AMERIFOODS TRADING COMPANY", "Contract Pharmacal Corp.", "SPIRIT PHARMACEUTICALS,LLC", "DOLGENCORP, LLC", "Bi-Mart", "SKYA HEALTH, LLC", "Family Dollar", "Gobrands, Inc", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Provision Medical Products", "CVS Pharmacy.Inc.", "Health Pharma USA LLC", "Strategic Sourcing Services, LLC", "Conney Safety Products, LLC", "Lil' Drug Store products, Inc.", "Sam's West, Inc.", "COSTCO WHOLESALE CORPORATION", "WALGREENS CO.", "AAA Pharmaceutical, Inc.", "EQUATE (WAL-MART STORES, INC.)", "EXELAN PHARMACEUTICALS, INC.", "HYVEE INC", "Salado Sales, Inc.", "Actavis Pharma, Inc.", "Florida Pharmaceutical Products, LLC", "7-Eleven", "BI-MART", "Meijer Distribution, Inc.", "Dr. Reddy's Laboratories Inc.", "AAFES/Your Military Exchanges", "DISCOUNT DRUG MART, INC.", "McKesson Medical-Surgical", "OPMX LLC", "PUBLIX SUPER MARKETS INC", "Medline industries, LP", "Vivunt Pharma LLC", "Whole Foods Market, INC.", "Care One (Retail 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{"reportercountry": "US", "qualification": "1"} | US | 20140424 | 102 | 20140312 | 102 | {"receivertype": "6", "receiverorganization": "FDA"} | {"duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014063856"} | 1 | 10003304 | 2 | {"sendertype": "2", "senderorganization": "FDA-Public Use"} | 2 | Empty | Empty | Empty | Empty | Empty | 20141212 | 102 |