{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 19162 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10055169", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140402", "receiptdateformat": "102", "receiptdate": "20140402", "fulfillexpeditecriteria": "1", "companynumb": "US-JNJFOC-20140318156", "duplicate": "1", "reportduplicate": { "duplicatesource": "MCNEIL", "duplicatenumb": "US-JNJFOC-20140318156" }, "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": "Cerebrovascular accident", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Blood pressure increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug administration error", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "NICOTINE POLACRILEX", "drugbatchnumb": "UNK", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "003", "drugdosageform": "Chewing Gum", "drugadministrationroute": "002", "drugindication": "SMOKING CESSATION THERAPY", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA203690", "ANDA074507", "ANDA074707", "ANDA078546", "ANDA090711", "ANDA076777", "ANDA076569", "ANDA076568", "ANDA204833", "ANDA078699", "ANDA078697", "ANDA078326", "ANDA076775", "ANDA077007", "ANDA208875", "ANDA207868", "ANDA079216", "ANDA078547", "ANDA079038", "ANDA076779", "ANDA206394", "ANDA212983", "ANDA078325", "M012", "ANDA209206", "ANDA079219", "NDA020066", "ANDA212796", "ANDA090821", "ANDA206393", "ANDA212057", "ANDA091354", "ANDA076789", "ANDA204794", "ANDA210711", "ANDA079044", "NDA021330", "ANDA212056", "NDA022360", "ANDA210712", "ANDA214354", "ANDA213266", "NDA018612", "ANDA213233", "ANDA091349" ], "brand_name": [ "NICOTINE MINI", "RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR", "QUITINE NICOTINE", "NICOTINE", "EQUATE NICOTINE", "NICOTINE POLACRILEX MINT", "NICOTINE POLACRILEX", "RUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR", "GOOD SENSE NICOTINE", "FOSTER AND THRIVE NICOTINE", "BASIC CARE NICOTINE", "MINI NICOTINE", "DG HEALTH NICOTINE", "TOPCARE NICOTINE", "NICOTINE GUM", "NICOTINE SUGAR FREE", "EXCHANGE SELECT NICOTINE", "CARE ONE NICOTINE", "NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE", "UP AND UP MINI NICOTINE", "UP AND UP MINT MINI NICOTINE", "CAREONE NICOTINE", "BERKLEY AND JENSEN NICOTINE", "TOPCARE NICOTINE POLACRILEX", "BLIP", "NICOTINE MINT FLAVOR", "QUITINE MINI NICOTINE", "RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR", "MEMBERS MARK MINI NICOTINE", "NICOTINE POLACRILEX COATED MINT", "KIRKLAND SIGNATURE QUIT 4", "NICOTINE POLACRILEX COATED ICE MINT", "SIGNATURE CARE NICOTINE", "UP AND UP NICOTINE", "NICOTINE POLACRILEX ORIGINAL FLAVOR", "NICOTINE POLACRILEX ORIGIANL FLAVOR", "NICOTINE LOZENGE", "NICORETTE", "HEB NICOTINE", "CAREONE MINI NICOTINE POLACRILEX", "KIRKLAND SIGNATURE QUIT 2", "REXALL NICOTINE", "NICOTINE POLACRILEX COATED FRUIT", "MEMBERS MARK NICOTINE", "BERKLEY AND JENSEN NICOTINE POLACRILEX", "UP AND UP MINT NICOTINE", "HABITROL NICOTINE POLACRILEX GUM 4 MG COATED FRUIT", "UP AND UP UNCOATED MINT NICOTINE", "EUQATE NICOTINE", "UP AND UP COATED MINT FREEZE NICOTINE", "HABITROL NICOTINE POLACRILEX 4 MG COATED CINNAMON", "MAXI NICOTINE", "HABITROL NICOTINE POLACRILEX GUM 2 MG COATED FRUIT", "HABITROL NICOTINE POLACRILEX GUM 4 MG COATED MINT", "UP AND UP CITRUS MINI NICOTINE", "NICOTINE POLACRILEX GUM", "AMAZON BASIC CARE NICOTINE POLACRILEX", "NICTOINE GUM", "STOP SMOKING AID", "NICORETTE PEPPERMINT", "NICORETTE CHERRY PEPPERMINT", "GOOD SENSE NICOTINE MINT", "UP AND UP UNCOATED ORIGINAL NICOTINE", "UP AND UP COATED CINNAMON NICOTINE", "NICORETTE ORIGINAL", "NICORETTE MINT", "NICORETTE SPEARMINT BURST", "NICORETTE CINNAMON SURGE", "NICORETTE WHITE ICE MINT", "NICOTINE POLACRILEX ORIGINAL", "NICORETTE 4MG WHITE ICE MINT GUM, LIL DRUG STORE", "UP AND UP NICOTINE MINI MINT", "RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR", "NICOTINE POLACRILEX COATED CINNAMON", "NICORETTE 4MG CINNAMON SURGE", "UP AND UP UNCOATED NICOTINE", "UP AND UP COATED COOL MINT NICOTINE", "UP AND UP CHERRY NICOTINE", "UP AND UP CHERRY ICE NICOTINE", "NICOTINE POLACRILEX, ORIGINAL", "NICORETTE FRUIT CHILL", "COATED NICOTINE", "HABITROL NICOTINE POLACRILEX 2 MG COATED CINNAMON", "UP AND UP COATED FRUIT NICOTINE", "HABITROL NICOTINE POLACRILEX GUM 2 MG COATED MINT" ], "generic_name": [ "NICOTINE POLACRILEX", "NICOTINE POLACRILEX GUM", "NICOTINE" ], "manufacturer_name": [ "Walgreen Company", "Rugby Laboratories", "QUITINE LLC", "Wal-Mart Stores Inc", "Walgreens", "L. Perrigo Company", "Strategic Sourcing Services LLC", "Advagen Pharma Limited", "Meijer, Inc.", "Amazon.com Services LLC", "P & L Development, LLC", "CVS Pharmacy", "Dolgencorp Inc", "Topco Associates LLC", "Dr. Reddy's Laboratories Inc.", "Guangzhou Shuimu Jiahe Trading Co., Ltd.", "Padagis Israel Pharmaceuticals Ltd", "Kroger Company", "Lucy Goods, Inc.", "Army & Air Force Exchange Service", "American Sales Company", "H E B", "Lil' Drug Store Products, Inc.", "AAFES/Your Military Exchanges", "Target Corporation", "Rite Aid Corporation", "BJWC", "McKesson Corporation dba SKY Packaging", "Blip Products, Inc.", "Meijer Distribution Inc", "Sam's West Inc", "Cardinal Health (Leader) 70000", "Publix Supermarkets, Inc.", "Costco Wholesale Company", "AmerisourceBergen (Good Neighbor Pharmacy) 46122", "WALMART INC.", "CARDINAL HEALTH 110, LLC. DBA LEADER 70000", "Safeway", "Rugby Laboratories, Inc.", "Haleon US Holdings LLC", "WALMART INC. (see also Equate)", "HyVee Inc", "Dolgencorp, LLC", "Rising Pharma Holdings, Inc.", "Quitine LLC", "Chain Drug Consortium, LLC", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "HC Jones, Inc.", "PLD Acquisitions LLC DBA Avma Pharma Solutions", "Fertin Pharma A/S", "The Kroger Co.", "Publix Super Markets Inc", "Family Dollar (FAMILY WELLNESS)", "Aurohealth LLC", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Lil' Drug Store products, Inc.", "EQUATE (Wal-Mart Stores, Inc.) 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DRUG" ], "route": [ "TRANSDERMAL" ], "substance_name": [ "NICOTINE" ], "rxcui": [ "198029", "198030", "198031", "351427", "351429", "351433" ], "spl_id": [ "39e81d62-9ad8-8f7f-e063-6394a90a17b2" ], "spl_set_id": [ "93b2d1b9-83c1-40b5-b6af-90c38c8d6cef" ], "package_ndc": [ "0135-0194-01", "0135-0194-02", "0135-0194-03", "0135-0194-08", "0135-0194-05", "0135-0195-02", "0135-0195-03", "0135-0195-08", "0135-0195-05", "0135-0196-02", "0135-0196-08", "0135-0196-05" ], "nui": [ "N0000175706", "M0014836" ], "pharm_class_epc": [ "Cholinergic Nicotinic Agonist [EPC]" ], "pharm_class_cs": [ "Nicotine [CS]" ], "unii": [ "6M3C89ZY6R" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ANTI-HYPERTENSIVE", "drugdosageform": "Unspecified", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5" } ] } } ] }