{
  "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": "2026-10-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "50332-0141",
      "generic_name": "Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, ,",
      "labeler_name": "HART Health",
      "brand_name": "CETAFEN COUGH and COLD",
      "active_ingredients": [
        {
          "name": "GUAIFENESIN",
          "strength": "100 mg/1"
        },
        {
          "name": "PHENYLEPHRINE HYDROCHLORIDE",
          "strength": "5 mg/1"
        },
        {
          "name": "ACETAMINOPHEN",
          "strength": "325 mg/1"
        },
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "10 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "50332-0141-3",
          "description": "20 PACKET in 1 BAG (50332-0141-3)  / 2 TABLET, FILM COATED in 1 PACKET",
          "marketing_start_date": "20230109",
          "sample": false
        },
        {
          "package_ndc": "50332-0141-4",
          "description": "40 PACKET in 1 BOX (50332-0141-4)  / 2 TABLET, FILM COATED in 1 PACKET",
          "marketing_start_date": "20230109",
          "sample": false
        },
        {
          "package_ndc": "50332-0141-7",
          "description": "100 PACKET in 1 BOX (50332-0141-7)  / 2 TABLET, FILM COATED in 1 PACKET",
          "marketing_start_date": "20230109",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "HART Health"
        ],
        "rxcui": [
          "1098435"
        ],
        "spl_set_id": [
          "44da0d8c-4a12-4122-99da-781e2809e1a8"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "495W7451VQ",
          "04JA59TNSJ",
          "362O9ITL9D",
          "9D2RTI9KYH"
        ]
      },
      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "TABLET, FILM COATED",
      "spl_id": "866ea7b4-cf9b-4001-a533-12b8f562e042",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20230109",
      "product_id": "50332-0141_866ea7b4-cf9b-4001-a533-12b8f562e042",
      "application_number": "M",
      "brand_name_base": "CETAFEN COUGH and COLD",
      "pharm_class": [
        "Adrenergic alpha1-Agonists [MoA]",
        "Decreased Respiratory Secretion Viscosity [PE]",
        "Expectorant [EPC]",
        "Increased Respiratory Secretions [PE]",
        "Sigma-1 Agonist [EPC]",
        "Sigma-1 Receptor Agonists [MoA]",
        "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]",
        "Uncompetitive NMDA Receptor Antagonists [MoA]",
        "alpha-1 Adrenergic Agonist [EPC]"
      ]
    }
  ]
}