{
  "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": 48175
    }
  },
  "results": [
    {
      "safetyreportversion": "2",
      "safetyreportid": "10005980",
      "primarysourcecountry": "GB",
      "occurcountry": "GB",
      "transmissiondateformat": "102",
      "transmissiondate": "20150720",
      "reporttype": "1",
      "serious": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20140313",
      "receiptdateformat": "102",
      "receiptdate": "20150221",
      "fulfillexpeditecriteria": "2",
      "companynumb": "GB-JNJFOC-20140303743",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "MCNEIL",
        "duplicatenumb": "GB-JNJFOC-20140303743"
      },
      "primarysource": {
        "reportercountry": "GB",
        "qualification": "1"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Angioedema",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Drug ineffective",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Pruritus",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Insomnia",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Condition aggravated",
            "reactionoutcome": "2"
          },
          {
            "reactionmeddraversionpt": "18.0",
            "reactionmeddrapt": "Chronic spontaneous urticaria",
            "reactionoutcome": "2"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "CETIRIZINE HYDROCHLORIDE.",
            "drugauthorizationnumb": "019835",
            "drugdosageform": "UNSPECIFIED",
            "drugadministrationroute": "065",
            "actiondrug": "5",
            "drugrecurreadministration": "3",
            "activesubstance": {
              "activesubstancename": "CETIRIZINE HYDROCHLORIDE"
            },
            "openfda": {
              "application_number": [
                "ANDA078336",
                "ANDA207235",
                "ANDA209274",
                "NDA019835",
                "ANDA091327",
                "ANDA090750",
                "ANDA090182",
                "ANDA077829",
                "ANDA210622",
                "ANDA218895",
                "ANDA090760",
                "ANDA076601",
                "ANDA090142",
                "ANDA078933",
                "ANDA209107",
                "ANDA090765",
                "ANDA213105",
                "ANDA078780",
                "ANDA078876",
                "ANDA213557",
                "ANDA201546",
                "NDA021621",
                "ANDA204226",
                "NDA022578",
                "NDA022155",
                "ANDA077498",
                "ANDA090254",
                "ANDA078343",
                "ANDA078692",
                "NDA211415",
                "ANDA090191",
                "ANDA090766",
                "ANDA212266",
                "ANDA078398",
                "ANDA078862",
                "ANDA077946",
                "ANDA220335",
                "ANDA090474",
                "ANDA078488",
                "ANDA076047",
                "ANDA076677",
                "ANDA078412"
              ],
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                "CAREONE ALLERGY RELIEF",
                "CURIST ALLERGY RELIEF",
                "DG HEALTH ALL DAY ALLERGY",
                "ZYRTEC HIVES",
                "CETIRIZINE HYDROCHLORIDE",
                "CHILDRENS ALLERGY RELIEF",
                "CHILDRENS CETIRIZINE HYDROCHLORIDE",
                "ALLERGY RELIEF",
                "ZYRTEC ALLERGY",
                "CETIRIZINE HYDROCHLORIDE (ALLERGY)",
                "CVS CETIRIZINE HYDROCHLORIDE",
                "BASIC CARE ALL DAY ALLERGY",
                "ALL DAY ALLERGY RELIEF",
                "TOPCARE ALL DAY ALLERGY",
                "SIMPLY RIGHT CHILDRENS CETIRIZINE",
                "BERKLEY AND JENSEN ALL DAY ALLERGY",
                "ALL DAY ALLERGY",
                "CHILDRENS ALLERGY",
                "EQUATE ALLERGY RELIEF",
                "WELBY ALLERGY RELIEF",
                "CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF",
                "PENTREXCILINA DAY TIME",
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                "24 HOUR ALLERGY",
                "UP AND UP CHILDRENS ALLERGY",
                "WAL-ZYR ALL DAY ALLERGY",
                "PREMIER VALUE CHILDRENS CETIRIZINE",
                "REXALL ALL DAY ALLERGY RELIEF",
                "EXCHANGE SELECT ALL DAY ALLERGY",
                "CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG (OVAL SHAPE)",
                "CETIRIZINE HYDROCHLORIDE TABLETS, 5 MG",
                "CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG",
                "CHILDRENS ZYRTEC",
                "AMAZON BASIC CARE ALL DAY ALLERGY RELIEF",
                "TOP CARE ALL DAY ALLERGY",
                "ALLERGY RELIEF CHILDRENS",
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                "KIRKLAND SIGNATURE ALLER TEC ALLERGY",
                "CABINET ALLERGY RELIEF",
                "CETIRIZINE",
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                "SIGNATURE CARE ALLERGY RELIEF",
                "EQUATE CHILDRENS ALLERGY RELIEF",
                "CETIRIZINE HYDROCHLORIDE HIVES RELIEF",
                "ALLERGY",
                "CHILDRENS CETIRZINE",
                "CETIRIZINE HYDROCHLORIDE TABLETS,10 MG",
                "QUZYTTIR",
                "VALUMEDS ALL DAY ALLERGY CETIRIZINE HYDROCHLORIDE",
                "CETIRIZINE HYDROCHLORIDE 10 MG",
                "QUALITY CHOICE CETIRIZINE HYDROCHLORIDE",
                "HEB ALLERGY RELIEF",
                "CABINET ALL DAY ALLERGY RELIEF",
                "CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)",
                "GOOD SENSE ALL DAY ALLERGY",
                "VALUMEDS 24-HOUR ALLERGY RELIEF",
                "ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES",
                "CHILDRENS ZYRTEC ALLERGY",
                "MEMBERS MARK ALLERGY RELIEF",
                "CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE",
                "WELBY CHILDRENS ALLERGY RELIEF",
                "UP AND UP ALLERGY RELIEF",
                "GOODNOW ALLERGY RELIEF",
                "CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY",
                "RIGHT REMEDIES ALL-DAY ALLERGY RELIEF",
                "CETRIZINE HYDROCHLORIDE",
                "RITE AID CHILDRENS ALLERGY RELIEF",
                "CABINET ALLERGY RELIEF REFILL CETIRIZINE HCI",
                "EQUALINE ALL DAY ALLERGY",
                "GOOD NEIGHBOR PHARMACY ALL DAY ALLERGY",
                "CRCLE CETIRIZINE HYDROCHLORIDE",
                "GOODMEDS ALL DAY ALLERGY RELIEF CETIRIZINE HCL"
              ],
              "generic_name": [
                "CETIRIZINE HYDROCHLORIDE",
                "CETIRIZINE",
                "CETIRIZINE HYDROCHLORIDE ALLERGY",
                "CETIRIZINE HYDROCHLORIDE TABLETS"
              ],
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                "GOOD NEIGHBOR PHARMACY ALL DAY ALLERGY",
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                "Dolgencorp Inc",
                "Kenvue Brands LLC",
                "BAJAJ MEDICAL, LLC",
                "C.D.M.A., Inc.",
                "Sun Pharmaceutical Industries, Inc.",
                "Prodose, Inc",
                "Strategic Sourcing Services",
                "Indoco Remedies Limited",
                "Aurohealth LLC",
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                "WALGREENS",
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                "Topco Associates LLC",
                "Sam's West Inc",
                "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.",
                "BJWC",
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                "LIDL US LLC",
                "HyVee Inc",
                "Publix Super Markets Inc",
                "Wal-Mart Stores Inc",
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                "KROGER COMPANY",
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                "H E B",
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                "Umasuto, LLC",
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                "Target Corporation",
                "WALGREEN COMPANY",
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                "Dolgencorp, LLC",
                "Army & Air Force Exchange Service",
                "MARKSANS PHARMA LIMITED",
                "Magno-Humphries, Inc.",
                "Ohm Laboratories Inc.",
                "Fred's, Inc.",
                "Walgreen Company",
                "Costco Wholesale Company",
                "Dr.Reddy's Laboratories Limited",
                "Spirit Pharmaceutical LLC",
                "LEADER/ CARDINAL HEALTH 110, INC.",
                "Major Pharmaceuticals",
                "Cardinal Health 110, LLC. dba Leader",
                "BETTER LIVING BRANDS, LLC",
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                "Rising Pharma Holdings, Inc.",
                "INNOVUS PHARMACEUTICALS, INC.",
                "Padagis Israel Pharmaceuticals Ltd",
                "Kroger Company",
                "NorthStar Rx LLC",
                "WALMART INC.",
                "Sandoz Inc",
                "MARC GLASSMAN, INC.",
                "TerSera Therapeutics LLC",
                "Cabinet Health P.B.C.",
                "STRATEGIC SOURCING SERVICES LLC",
                "Camber Consumer Care Inc",
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                "FAMILY DOLLAR SERVICES, INC",
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                "CHAIN DRUG MARKETING ASSOCIATION, INC.",
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                "Aventura Pharmaceuticals, LLC",
                "WINCO FOODS, LLC",
                "Meijer, Inc.",
                "Strive Pharmaceuticals Inc.",
                "APOZEAL PHARMACEUTICALS INC",
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                "Granules USA, Inc.",
                "VALU MERCHANDISERS COMPANY",
                "Marc Glassman, Inc.",
                "TOPCO ASSOCIATES LLC",
                "PD-Rx Pharmaceuticals, Inc.",
                "Mylan Pharmaceuticals Inc.",
                "Innovus Pharmaceuticals, Inc.",
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