{
  "meta": {
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    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-30",
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                "Astellas Pharma US, Inc."
              ],
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                "51248-151"
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                "HUMAN PRESCRIPTION DRUG"
              ],
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                "51248-151-03",
                "51248-151-01"
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              "unii": [
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            }
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            "drugseparatedosagenumb": "1",
            "drugdosagetext": "UNK",
            "drugdosageform": "Tablet",
            "drugindication": "Product used for unknown indication",
            "activesubstance": {
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                "ANDA207235",
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                "ANDA078488",
                "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",
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                "ALL DAY ALLERGY RELIEF",
                "TOPCARE ALL DAY ALLERGY",
                "SIMPLY RIGHT CHILDRENS CETIRIZINE",
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                "BERKLEY AND JENSEN ALL DAY ALLERGY",
                "ALL DAY ALLERGY",
                "CHILDRENS ALLERGY",
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                "WELBY ALLERGY RELIEF",
                "CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF",
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                "UP AND UP CHILDRENS ALLERGY",
                "WAL-ZYR ALL DAY ALLERGY",
                "CETIRIZINE HYDROCHLORIDE - HIVES",
                "PREMIER VALUE CHILDRENS CETIRIZINE",
                "REXALL ALL DAY ALLERGY RELIEF",
                "EXCHANGE SELECT ALL DAY ALLERGY",
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                "CETIRIZINE HYDROCHLORIDE TABLETS, 5 MG",
                "CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG",
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                "TOP CARE ALL DAY ALLERGY",
                "MEMBERS MARK CHILDRENS CETIRIZINE",
                "KIRKLAND SIGNATURE ALLER TEC ALLERGY",
                "CABINET ALLERGY RELIEF",
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                "LEADER ALL DAY ALLERGY",
                "SIGNATURE CARE ALLERGY RELIEF",
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                "CETIRIZINE HYDROCHLORIDE HIVES RELIEF",
                "ALLERGY",
                "CHILDRENS CETIRZINE",
                "CETIRIZINE HYDROCHLORIDE TABLETS,10 MG",
                "VALUMEDS ALL DAY ALLERGY CETIRIZINE HYDROCHLORIDE",
                "CETIRIZINE HYDROCHLORIDE 10 MG",
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                "CABINET ALL DAY ALLERGY RELIEF",
                "CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)",
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                "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": [
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                "CETIRIZINE HYDROCHLORIDE ALLERGY",
                "CETIRIZINE HYDROCHLORIDE TABLETS"
              ],
              "manufacturer_name": [
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                "American Sales Company",
                "Little Pharma, Inc.",
                "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",
                "CVS Pharmacy",
                "OHM LABORATORIES INC.",
                "WALGREENS",
                "Amazon.com Services LLC",
                "RITE AID CORPORATION",
                "Amneal Pharmaceuticals LLC",
                "DOLGENCORP, INC.",
                "Topco Associates LLC",
                "Sam's West Inc",
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                "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.",
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                "Publix Super Markets Inc",
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                "KROGER COMPANY",
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                "OPMX LLC",
                "H E B",
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                "Umasuto, LLC",
                "BluePoint Laboratories",
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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",
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                "Dr. Reddy's Laboratories Inc.",
                "Rising Pharma Holdings, Inc.",
                "INNOVUS PHARMACEUTICALS, INC.",
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                "Sandoz Inc",
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                "FAMILY DOLLAR SERVICES, INC",
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                "United Natural Foods, Inc. dba UNFI",
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                "CHAIN DRUG MARKETING ASSOCIATION, INC.",
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                "Marc Glassman, Inc.",
                "TOPCO ASSOCIATES LLC",
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                "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.",
                "Amerisource Bergen",
                "Target Corporation",
                "Shield Pharmaceuticals Corp",
                "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",
                "Strides Pharma Inc.",
                "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.",
                "Family Dollar (FAMILY WELLNESS)",
                "Westminster Pharmaceuticals, LLC",
                "Chain Drug Marketing Association, Inc.",
                "VALU MERCHANDISERS COMPANY",
                "TIME CAP LABORATORIES, INC.",
                "FSA Store Inc. (Caring Mills)",
                "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.",
                "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.",
                "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",
                "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."
              ],
              "product_ndc": [
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                "11822-3307",
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                "62332-350-30",
                "62332-350-90",
                "62332-350-71",
                "62332-351-30",
                "62332-351-90",
                "62332-351-71",
                "13668-440-01",
                "13668-440-90",
                "13668-440-05",
                "13668-439-90",
                "13668-439-01",
                "13668-439-05",
                "13668-438-90",
                "13668-438-01",
                "13668-438-05",
                "0115-5511-10",
                "0115-5511-01",
                "0115-5511-02",
                "0115-5511-03",
                "0115-5522-10",
                "0115-5522-01",
                "0115-5522-02",
                "0115-5522-03",
                "73352-101-01",
                "73352-102-01"
              ],
              "nui": [
                "N0000175596",
                "N0000175375",
                "M0543661"
              ],
              "pharm_class_epc": [
                "Peroxisome Proliferator Receptor alpha Agonist [EPC]"
              ],
              "pharm_class_moa": [
                "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"
              ],
              "pharm_class_cs": [
                "Fibric Acids [CS]"
              ],
              "unii": [
                "U202363UOS"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "RETATRUTIDE",
            "drugseparatedosagenumb": "1",
            "drugdosagetext": "UNK",
            "drugindication": "Product used for unknown indication",
            "activesubstance": {
              "activesubstancename": "RETATRUTIDE"
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "PRAMIPEXOLE",
            "drugseparatedosagenumb": "1",
            "drugdosagetext": "UNK",
            "drugdosageform": "Tablet",
            "drugindication": "Product used for unknown indication",
            "activesubstance": {
              "activesubstancename": "PRAMIPEXOLE"
            },
            "openfda": {
              "application_number": [
                "ANDA203855"
              ],
              "brand_name": [
                "PRAMIPEXOLE"
              ],
              "generic_name": [
                "PRAMIPEXOLE"
              ],
              "manufacturer_name": [
                "Camber Pharmaceuticals, Inc."
              ],
              "product_ndc": [
                "31722-906",
                "31722-907",
                "31722-908",
                "31722-909",
                "31722-910",
                "31722-911"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "PRAMIPEXOLE DIHYDROCHLORIDE"
              ],
              "rxcui": [
                "858625",
                "859033",
                "859040",
                "859044",
                "859048",
                "859052"
              ],
              "spl_id": [
                "540a17f8-b64d-41e1-a96b-d55bc8c48f3d"
              ],
              "spl_set_id": [
                "a7405a56-de1c-4875-b57f-210c991474ba"
              ],
              "package_ndc": [
                "31722-906-90",
                "31722-906-10",
                "31722-906-05",
                "31722-907-90",
                "31722-907-10",
                "31722-907-05",
                "31722-908-90",
                "31722-908-10",
                "31722-908-05",
                "31722-909-90",
                "31722-909-10",
                "31722-909-05",
                "31722-910-90",
                "31722-910-10",
                "31722-910-05",
                "31722-911-90",
                "31722-911-10",
                "31722-911-05"
              ],
              "unii": [
                "3D867NP06J"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20190601"
        }
      }
    }
  ]
}