{
  "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,
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  },
  "results": [
    {
      "product_ndc": "50580-402",
      "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride",
      "labeler_name": "Kenvue Brands LLC",
      "brand_name": "TYLENOL Cold Plus Flu Severe",
      "brand_name_suffix": "Severe",
      "active_ingredients": [
        {
          "name": "ACETAMINOPHEN",
          "strength": "325 mg/1"
        },
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "10 mg/1"
        },
        {
          "name": "GUAIFENESIN",
          "strength": "200 mg/1"
        },
        {
          "name": "PHENYLEPHRINE HYDROCHLORIDE",
          "strength": "5 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "50580-402-01",
          "description": "2 TABLET, FILM COATED in 1 POUCH (50580-402-01)",
          "marketing_start_date": "20170707",
          "sample": false
        },
        {
          "package_ndc": "50580-402-02",
          "description": "50 POUCH in 1 CARTON (50580-402-02)  / 2 TABLET, FILM COATED in 1 POUCH",
          "marketing_start_date": "20170707",
          "sample": false
        },
        {
          "package_ndc": "50580-402-26",
          "description": "2 BLISTER PACK in 1 CARTON (50580-402-26)  / 12 TABLET, FILM COATED in 1 BLISTER PACK",
          "marketing_start_date": "20120711",
          "sample": false
        },
        {
          "package_ndc": "50580-402-72",
          "description": "3 CARTON in 1 PACKAGE (50580-402-72)  / 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK",
          "marketing_start_date": "20120711",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {},
      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "TABLET, FILM COATED",
      "spl_id": "5c393efd-40ac-6e38-e063-6394a90ae753",
      "product_type": "HUMAN OTC DRUG",
      "route": [
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      ],
      "marketing_start_date": "20110901",
      "product_id": "50580-402_5c393efd-40ac-6e38-e063-6394a90ae753",
      "application_number": "M012",
      "brand_name_base": "TYLENOL Cold Plus Flu",
      "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]"
      ]
    }
  ]
}