{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "PARODONTAX"
        ],
        "generic_name": [
          "CETYLPYRIDINIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0135-0650",
          "0135-0651"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETYLPYRIDINIUM CHLORIDE"
        ],
        "rxcui": [
          "1100924"
        ],
        "spl_id": [
          "34a4093a-3aa9-3c7b-e063-6294a90a961a"
        ],
        "spl_set_id": [
          "444f931d-5e38-4cda-97ba-98aa0b5fe4f6"
        ],
        "package_ndc": [
          "0135-0651-02",
          "0135-0651-03",
          "0135-0650-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "D9OM4SK49P"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98198",
      "recalling_firm": "Haleon US Holdings LLC",
      "address_1": "184 Liberty Corner Rd Ste 200",
      "address_2": "N/A",
      "postal_code": "07059-6870",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0297-2026",
      "product_description": "parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02",
      "product_quantity": "84,764 bottles",
      "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.",
      "recall_initiation_date": "20251226",
      "center_classification_date": "20260126",
      "report_date": "20260204",
      "code_info": "Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle."
    }
  ]
}