{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0280-8294",
      "generic_name": "acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride",
      "labeler_name": "Bayer HealthCare LLC.",
      "brand_name": "Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels",
      "active_ingredients": [
        {
          "name": "GUAIFENESIN",
          "strength": "200 mg/1"
        },
        {
          "name": "ACETAMINOPHEN",
          "strength": "325 mg/1"
        },
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "10 mg/1"
        },
        {
          "name": "PHENYLEPHRINE HYDROCHLORIDE",
          "strength": "5 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0280-8294-24",
          "description": "3 BLISTER PACK in 1 CARTON (0280-8294-24)  / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
          "marketing_start_date": "20260601",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Bayer HealthCare LLC."
        ],
        "rxcui": [
          "1656815"
        ],
        "spl_set_id": [
          "51a45db8-2bee-6fd0-e063-6394a90ab587"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0016500584209"
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "495W7451VQ",
          "362O9ITL9D",
          "9D2RTI9KYH",
          "04JA59TNSJ"
        ]
      },
      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "CAPSULE, LIQUID FILLED",
      "spl_id": "51a45db8-2bef-6fd0-e063-6394a90ab587",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20260601",
      "product_id": "0280-8294_51a45db8-2bef-6fd0-e063-6394a90ab587",
      "application_number": "M012",
      "brand_name_base": "Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels",
      "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]"
      ]
    }
  ]
}