{ "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": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "19242786", "primarysourcecountry": "CA", "occurcountry": "CA", "transmissiondateformat": "102", "transmissiondate": "20210717", "reporttype": "3", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20210510", "receiptdateformat": "102", "receiptdate": "20210510", "fulfillexpeditecriteria": "1", "companynumb": "CA-CELLTRION INC.-2021CA006164", "duplicate": "1", "reportduplicate": { "duplicatesource": "CELLTRION", "duplicatenumb": "CA-CELLTRION INC.-2021CA006164" }, "primarysource": { "reportercountry": "CA", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": 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"pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ], "unii": [ "JCX84Q7J1L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "XELJANZ", "drugbatchnumb": "UNKNOWN", "drugadministrationroute": "065", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "TOFACITINIB CITRATE" }, "openfda": { "application_number": [ "NDA208246", "NDA203214", "NDA213082" ], "brand_name": [ "XELJANZ XR", "XELJANZ" ], "generic_name": [ "TOFACITINIB" ], "manufacturer_name": [ "Pfizer Laboratories Div Pfizer Inc", "U.S. Pharmaceuticals" ], "product_ndc": [ "0069-0501", "0069-1001", "0069-1002", "0069-0502", "0069-1029", "63539-012", "63539-501", "63539-016", "63539-502", "63539-029" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "TOFACITINIB CITRATE" ], "rxcui": [ "1357541", "1357547", "1741046", "1741049", "2048566", "2048568", "2273113", 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"STOMACH RELIEF REGULAR STRENGTH", "PEPTO-BISMOL CHERRY", "TREDA ULTRA", "MAJOR BISMUTH SUBSALICYLATE", "KAOPECTATE VANILLA FLAVOR ANTI DIARRHEAL", "STOMACH RELIEF", "WALGREEN", "TOPCO STOMACH RELIEF", "GASTROBIZ", "FIRST AID DIRECT PEPTUM TABS", "5 SYMPTOM DIGESTIVE RELIEF", "BISMUTH SUBSALICYLATE 262 MG", "RIGHT REMEDIES STOMACH RELIEF BISMUTH SUBSALICYLATE 262 MG SOFTGEL", "WINCO FOODS ULTRA STRENGTH STOMACH RELIEF", "HEB STOMACH RELIEF CHERRY", "PEPTO BISMOL CHEWABLES", "PERCY MEDICINE", "TOPCARE STOMACH RELIEF CHERRY", "GREEN GUARD INSTYDOSE UPSET STOMACH RELIEF", "PEPTO BISMOL FAST MELTS WINTER FROST FLAVORED", "AMAZON DIGESTIVE RELIEF", "FEVIA DIARRHEA CONTROL", "WALGREEN STOMACH RELIEF", "ULTRA STRENGTH DIGESTIVE RELIEF", "KROGER REGULAR STRENGTH PINK BISMUTH", "ESTOMAQUIL POLVO", "UP AND UP 5-SYMPTOM DIGESTIVE RELIEF", "PEPT-ACHE", "FOSTER AND THRIVE STOMACH RELIEF", "RAPIDOL STOMACH RELIEF", "BISMUTH", "MEIJER STOMACH RELIEF REGULAR STRENGTH", "SOOTHE", "PEPTO-BISMOL", "PEPTO BISMOL LIQUICAPS", "MEIJER STOMACH RELIEF", "PEPTO RELIEF", "ANTI-DIARRHEAL", "STOMACH RELIEVER", "DIGESTIVE RELIEF", "UP AND UP DIGESTIVE RELIEF", "RITE AID STOMACH RELIEF ORIGINAL FLAVOR", "STOMACH RELIEF MAXIMUM STRENGTH", "ULTRA BISMUTH", "EQUALINE STOMACH RELIEF", "STOMACH RELIEF ULTRA STRENGTH", "PEPTO BISMOL CHEWS", "KAOPECTATE MAX PEPPERMINT FLAVOR ANTI DIARRHEAL", "DIGESTIVE RELIEF REGULAR STRENGTH", "MAX STRENGTH STOMACH RELIEF", "REVASOL PEPTIC RELIEF", "ULTRA STOMACH RELIEF", "MCKESSON BISMUTH", "PEPTO BISMOL ULTRA", "REGULAR STRENGTH STOMACH RELIEF", "HEB STOMACH RELIEF", "MEDIQUE DIOTAME", "PEPTO-BISMOL CHEWABLE, TRAVEL BASIX", "PEPTO-BISMOL CHEWABLE, CVP HEALTH", "TOPCARE STOMACH RELIEF ORIGINAL STRENGTH", "KAOPECTATE PEPPERMINT FLAVOR ANTI DIARRHEAL", "PINK BISMUTH", "PEPTO-BISMOL ULTRA", "STOMACH RELIEF ORIGINAL STRENGTH", "POCKET PEPTO PEPTO BISMOL", "BISMUTINA", "GOODSENSE REGULAR STRENGTH STOMACH RELIEF 122", "WALGREENS BISMUTH STOMACH RELIEF", "RITE AID DIGESTIVE RELIEF", "PUBLIX REGULAR STRENGTH PINK BISMUTH", "CVS HEALTH STOMACH RELIEF CHERRY FLAVOR", "CVS HEALTH ANTI-DIARRHEAL VANILLA", "QC STOMACH RELIEF CHERRY FLAVOR", "RITE AID STOMACH RELIEF", "BISMUTH SUBSALICYLATE SUSPENSION REGULAR STRENGTH", "5-SYMPTOM DIGESTIVE RELIEF", "WINCO FOODS STOMACH RELIEF", "PREMIER VALUE", "QC STOMACH RELIEF REGULAR STRENGTH", "STOMACH RELIEF - REGULAR STRENGTH", "CVS STOMACH RELIEF ULTRA STRENGTH", "WALGREEN ULTRA STRENGTH PINK BISMUTH", "QC PINK BISMUTH", "STOMACH RELIEF - MAXIMUM STRENGTH", "MAXIMUM STRENGTH PINK BISMUTH", "GOOD NEIGHBOR ULTRA STRENGTH STOMACH RELIEF", "PEP TUM", "GUARDIAN PINK BISMUTH", "GNP PINK BISMUTH", "CVS HEALTH STOMACH RELIEF SOFTGEL", "SIGNATURE CARE REGULAR STRENGTH", "DYE FREE REGULAR STRENGTH STOMACH RELIEF", "HEB STOMACH RELIEF MAX STRENGTH", "SOOTHE ULTRA STRENGTH", "STOMACH CIRCLE K", "STOMACH LIL DRUG STORE PRODUCTS", "RITE AID ULTRA STRNGHT PINK BISMUTH", "MAXIMUM STRENGTH STOMACH RELIEF", "PINK-BISMUTH", "PEPTO BISMOL", "PINK BISMUTH REGULAR STRENGTH", "BISMUTH SUBSALICYLATE", "ULTRA STRENGHT PINK BISMUTH", "KROGER STOMACH RELIEF", "THOMPSON CHEWABLE BISMUTH TABS", "PREMIER VALUE DIARRHEA RELIEF VANILLA FLAVOR", "ULTRA STRENGTH STOMACH RELIEF", "KROGER DIGESTIVE RELIEF", "EQUALINE MAXIMUM STRENGTH STOMACH RELIEF", "MEDI-FIRST PEP-T-MED", "STOMACH RELIEF, ULTRA STRENGTH", "QUALITY CHOICE STOMACH RELIEF 528", "SIGNATURE CARE ULTRA STRENGTH STOMACH", "BISMUTH SUBSALICYLATE PINK BISMUTH", "MEDIQUE DIOTAME INSTYDOSE", "TOPCARE STOMACH RELIEF REGULAR STRENGTH", "TOPCARE STOMACH RELIEF ULTRA STRENGTH", "CVS STOMACH RELIEF", "RITE AID REGULAR STRNGTH PINK BISMUTH", "QUALITY CHOICE REGULAR STRENGTH STOMACH RELIEF", "DRX CHOICE STOMACH RELIEF REGULAR STRENGTH", "EQUATE BISMUTH STOMACH RELIEF CHEW", "TOPCARE ULTRA STRENGTH STOMACH RELIEF", "WALGREEN STOMACH RELIEF ULTRA STRENGTH", "QUALITY CHOICE ULTRA STRENGTH STOMACH RELIEF", "QC ANTI DIARRHEAL VANILLA REGULAR FLAVOR", "HEB STOMACH RELIEF REGULAR STRENGTH", "PEPTO BISMOL FAST MELTS FRESH BERRY FLAVORED", "TOPCARE REGULAR STRENGTH", "PUBLIX STOMACH RELIEF ULTRA STRENGTH", "RITE AID REGULAR STRENGTH PINK BISMUTH", "PEPTO-BISMOL ULTRA CHERRY", "STOMACH RELIEF, MAXIMUM STRENGTH", "QCH STOMACH RELIEF 535", "GUARDIAN PINK-BISMUTH CHERRY", "CAREONE STOMACH RELIEF", "FAMILY WELLNESS STOMACH RELIEF" ], "generic_name": [ "BISMUTH SUBSALICYLATE" ], "manufacturer_name": [ "CVS PHARMACY, INC.", "Kramer Laboratories", "Family Dollar (FAMILY WELLNESS)", "AMAZON.COM SERVICES LLC", "Good Sense (Geiss, Destin & Dunn, Inc.)", "Wal-Mart Stores, Inc.", "PUBLIX SUPER MARKETS INC,", "Rugby Laboratories", "The Procter & Gamble Manufacturing Company", "Laboratorios Sanfer, S.A. de C.V.", "Major Pharmaceuticals", "Grocery Outlet, Inc.", "WALGREEN CO.", "Topco Associates, LLC", "Allegiant Health", "Cintas Corp", "TARGET CORPORATION", "Reliable 1 Laboratories LLC", "Consumer Value Products, Inc.", "Strive Pharmaceuticals Inc.", "WALMART INC. (see also Equate)", "WINCO FOODS", "H E B", "Procter & Gamble Manufactura S de RL de CV", "Merrick Medicine Company, Inc", "Unifirst First Aid Corporation", "VIVUNT PHARMA LLC", "WALGREENS CO.", "THE KROGER CO.", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "KROGER COMPANY", "ProMex LLC", "Target Corporation", "JHK Inc dba American Safety & First Aid", "Strategic Sourcing Services LLC", "Pharmadel LLC", "MEIJER DISTRIBUTION INC", "Walgreens", "Meijer Distribution Inc", "Advance Pharmaceutical Inc.", "Lil' Drug Store Products, Inc.", "CVS Pharmacy", "Hyvee Inc", "SAFEWAY", "RITE AID CORPORATION", "Raritan Pharmaceuticals Inc", "Rite Aid Corporation", "Best Choice (Valu Merchandisers Company)", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "UNITED NATURAL FOODS, INC. DBA UNFI", "Cardinal Health (Leader) 70000", "P & L Development, LLC", "TARGET Corporation", "Harris Teeter, LLC", "Rnv LLC", "Safeway, Inc.", "McKesson Medical-Surgical", "DOLGENCORP, INC.", "Demoulas Super Markets Inc", "Gobrands, Inc. (Goodnow)", "TopCo Associates, LLC", "Discount Drug Mart, Inc", "YOUR MILITARY EXCHANGE", "Menper Distributors, Inc.", "PUBLIX SUPER MARKETS, INC", "CVS PHARMACY,INC.", "CVS Pharmacy,Inc.", "QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)", "FSA Store Inc. (Caring Mill)", "CHAIN DRUG CONSORTIUM,LLC", "AptaPharma Inc.", "CVS PHARMACY", "AMERISOURCE BERGEN", "First Aid Direct", "Guardian Drug Company", "Amerisource Bergen", "CVS Pharmacy, Inc.", "WINCO FOODS LLC", "Shield Pharmaceuticals Corp", "Richmond Pharmaceuticals, Inc", "Walmart Inc.", "WALGREEN COMPANY", "HEB", "Lil' Drug Store Products, Inc", "CVS", "Care One (Retail Business Services, LLC.)", "PuraCap Pharmaceutical LLC", "CARDINAL HEALTH 110, LLC. DBA LEADER", "Thompson Safety LLC", "PHARMACY VALUE ALLIANCE, LLC", "Marc Glassman, Inc.", "Chain Drug Marketing Association Inc.", "TOPCO ASSOCIATES LLC", "LEADER/ Cardinal Health 110, Inc.", "Procter & Gamble Manufactura, S. de R.L. de C.V.", "RARITAN PHAMACEUTICALS INC", "Chain Drug Marketing Association, Inc.", "CDMA- QC", "Walmart", "KRAMER LABORATORIES", "Rugby Laboratories, Inc.", "The Kroger Co.", "Wal-Mart Stores Inc", "Retail Business Services, LLC.", "Family Dollar Services, Inc.", "Softgel Healthcare Pvt Ltd" ], "product_ndc": [ "69842-766", "55505-197", "55319-948", "72288-706", "50804-154", "79903-089", "41415-124", "0536-1286", "37000-439", "83393-749", "0904-7205", "55505-198", "85828-791", "0363-9125", "36800-104", "69168-999", "42961-109", "11673-723", "69618-029", "57243-557", "70692-829", "79903-311", "67091-363", "37808-587", "58933-011", "0322-2222", "36800-769", "47682-770", "69423-832", "72288-125", "55505-206", "82706-028", "0363-1423", "30142-138", 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"0363-7071", "83324-337", "0536-1287", "49035-725", "41163-535", "63868-339", "55910-837", "30142-680", "37808-607", "69423-831", "36800-661", "69842-172", "49580-0724", "21130-624", "49035-346", "41415-707", "30142-624", "69256-527", "11822-7060", "79903-443", "37000-441", "37808-346", "0363-0073", "21130-241", "76281-558", "70677-1080", "83324-022", "53041-022", "72476-173", "49580-0624", "55319-122", "35916-0234", "72476-736", "37000-438" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BISMUTH SUBSALICYLATE", "BISMUTH" ], "rxcui": [ "308762", "308760", "642349", "308763", "308761", "211176", "1998447", "642346", "2121072", "211151", "616343", "1233767", "2476644", "1721449", "1721455", "702384", "2121074", "1043048", "211915", "1998449" ], "spl_id": [ "aa812cd2-240c-42da-81bb-75047d6aeba0", "eb3ecda3-180e-4a04-9089-5cceabe22724", "4919c1ef-67db-4283-99dd-5307499007e4", "6b41f36d-1810-45f7-a46c-67b9bff23738", "c0b2097e-f207-4de0-b000-add6f5bfdae4", 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INFANTIS" } }, { "drugcharacterization": "2", "medicinalproduct": "ETHINYLESTRADIOL;NORGESTIMATE", "drugbatchnumb": "UNKNOWN", "actiondrug": "5", "drugadditional": "3" } ] } } ] }