{
  "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": 10,
      "total": 19157
    }
  },
  "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",
                "M012",
                "ANDA076779",
                "ANDA206394",
                "ANDA206393",
                "ANDA212983",
                "ANDA078325",
                "ANDA209206",
                "ANDA079219",
                "NDA020066",
                "ANDA212796",
                "ANDA090821",
                "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",
                "ONEOO NICOTINE GUM (MINT)",
                "ONEOO NICOTINE GUM (GRAPE)",
                "ONEOO NICOTINE GUM (3 FLAVORS)",
                "ONEOO NICOTINE GUM (CINNAMON)",
                "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",
                "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",
                "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 NICOTINE",
                "UP AND UP CITRUS MINI NICOTINE",
                "NICOTINE POLACRILEX GUM",
                "AMAZON BASIC CARE NICOTINE POLACRILEX",
                "NICTOINE GUM",
                "STOP SMOKING AID",
                "NICORETTE PEPPERMINT",
                "NICORETTE CHERRY PEPPERMINT",
                "COATED NICOTINE",
                "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",
                "NICOTINE COATED",
                "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",
                "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",
                "Guangzhou Shuimu Jiahe Trading Co., Ltd.",
                "CVS Pharmacy",
                "Dolgencorp Inc",
                "Publix Super Markets Inc",
                "Topco Associates LLC",
                "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED",
                "Dr. Reddy's Laboratories Inc.",
                "Padagis Israel Pharmaceuticals Ltd",
                "Kroger Company",
                "WALMART INC.",
                "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.",
                "Sam's West Inc",
                "Cardinal Health (Leader) 70000",
                "Meijer Distribution Inc",
                "Publix Supermarkets, Inc.",
                "Costco Wholesale Company",
                "AmerisourceBergen (Good Neighbor Pharmacy) 46122",
                "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.",
                "Family Dollar (FAMILY WELLNESS)",
                "Aurohealth LLC",
                "Lil' Drug Store products, Inc.",
                "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)"
              ],
              "product_ndc": [
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              "product_type": [
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                "LOW DOSE ASPIRIN ENTERIC SAFETY COATED",
                "ASPIRIN 81MG ENTERIC COATED",
                "CHILDRENS ASPIRIN",
                "CVS EFFERVESCENT PAIN RELIEVER",
                "BASIC CARE ASPIRIN",
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                "ASPIRIN ENTERIC COATED, REGULAR STRENGTH",
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                "ASPIRIN ENTERIC SAFETY COATED",
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                "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",
                "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",
                "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",
                "UP AND UP CHEWABLE 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",
                "H E B",
                "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.",
                "Valu Merchandisers Company",
                "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.",
                "Major Pharmaceuticals",
                "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)",
                "Unishield",
                "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",
                "Geri-Care Pharmaceuticals, Corp",
                "Family Dollar Services Inc",
                "Dolgencorp, Inc",
                "Pinnacle RX LLC",
                "GOODSENSE",
                "Health Pharma USA, LLC",
                "TWIN MED LLC",
                "Pioneer Life Sciences, LLC",
                "Meijer Distribution Inc",
                "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",
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          },
          {
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              ],
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              ],
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                "Cytochrome P450 3A Inhibitors [MoA]",
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        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 2014"
        }
      }
    }
  ]
}