{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "50580-786",
      "generic_name": "Cetirizine Hydrochloride",
      "labeler_name": "Kenvue Brands LLC",
      "brand_name": "ZYRTEC Allergy",
      "active_ingredients": [
        {
          "name": "CETIRIZINE HYDROCHLORIDE",
          "strength": "10 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "50580-786-12",
          "description": "1 BOTTLE in 1 PACKAGE (50580-786-12)  / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE",
          "marketing_start_date": "20240415",
          "sample": false
        },
        {
          "package_ndc": "50580-786-13",
          "description": "1 BOTTLE in 1 CARTON (50580-786-13)  / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE",
          "marketing_start_date": "20241201",
          "sample": false
        },
        {
          "package_ndc": "50580-786-25",
          "description": "1 BOTTLE in 1 PACKAGE (50580-786-25)  / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE",
          "marketing_start_date": "20240415",
          "sample": false
        },
        {
          "package_ndc": "50580-786-26",
          "description": "1 BOTTLE in 1 CARTON (50580-786-26)  / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE",
          "marketing_start_date": "20241201",
          "sample": false
        },
        {
          "package_ndc": "50580-786-40",
          "description": "1 BOTTLE in 1 PACKAGE (50580-786-40)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE",
          "marketing_start_date": "20240415",
          "sample": false
        },
        {
          "package_ndc": "50580-786-41",
          "description": "1 BOTTLE in 1 CARTON (50580-786-41)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE",
          "marketing_start_date": "20241201",
          "sample": false
        },
        {
          "package_ndc": "50580-786-65",
          "description": "65 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-786-65)",
          "marketing_start_date": "20240415",
          "sample": false
        },
        {
          "package_ndc": "50580-786-66",
          "description": "65 CAPSULE, LIQUID FILLED in 1 PACKAGE (50580-786-66)",
          "marketing_start_date": "20241201",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Kenvue Brands LLC"
        ],
        "rxcui": [
          "1014675",
          "1020023"
        ],
        "spl_set_id": [
          "0face45c-af24-3559-e063-6294a90abde5"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300450204318"
        ],
        "unii": [
          "64O047KTOA"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "CAPSULE, LIQUID FILLED",
      "spl_id": "41a5a9a1-61a6-f771-e063-6294a90aed87",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20240415",
      "product_id": "50580-786_41a5a9a1-61a6-f771-e063-6294a90aed87",
      "application_number": "ANDA213105",
      "brand_name_base": "ZYRTEC Allergy",
      "pharm_class": [
        "Histamine H1 Receptor Antagonists [MoA]",
        "Histamine-1 Receptor Antagonist [EPC]"
      ]
    }
  ]
}