{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0280-0088",
      "generic_name": "chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide",
      "labeler_name": "Bayer HealthCare LLC.",
      "brand_name": "Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz",
      "active_ingredients": [
        {
          "name": "ACETAMINOPHEN",
          "strength": "250 mg/1"
        },
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "10 mg/1"
        },
        {
          "name": "CHLORPHENIRAMINE MALEATE",
          "strength": "2 mg/1"
        },
        {
          "name": "PHENYLEPHRINE HYDROCHLORIDE",
          "strength": "5 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0280-0088-01",
          "description": "20 POUCH in 1 CARTON (0280-0088-01)  / 2 TABLET, EFFERVESCENT in 1 POUCH",
          "marketing_start_date": "20220405",
          "sample": false
        },
        {
          "package_ndc": "0280-0088-02",
          "description": "12 POUCH in 1 CARTON (0280-0088-02)  / 2 TABLET, EFFERVESCENT in 1 POUCH",
          "marketing_start_date": "20230308",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Bayer HealthCare LLC."
        ],
        "rxcui": [
          "1536477"
        ],
        "spl_set_id": [
          "a2f0285b-8550-fd26-e053-2995a90ab615"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0016500598848"
        ],
        "unii": [
          "362O9ITL9D",
          "9D2RTI9KYH",
          "V1Q0O9OJ9Z",
          "04JA59TNSJ"
        ]
      },
      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "TABLET, EFFERVESCENT",
      "spl_id": "45265106-f83e-e8a2-e063-6294a90a475c",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20220405",
      "product_id": "0280-0088_45265106-f83e-e8a2-e063-6294a90a475c",
      "application_number": "M012",
      "brand_name_base": "Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz",
      "pharm_class": [
        "Adrenergic alpha1-Agonists [MoA]",
        "Histamine H1 Receptor Antagonists [MoA]",
        "Histamine-1 Receptor Antagonist [EPC]",
        "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]"
      ]
    }
  ]
}