{
  "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": "2026-10-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "53041-616",
      "generic_name": "Acteaminophen, Guaifenesin, Phenylephrine HCl",
      "labeler_name": "Guardian Drug Company",
      "brand_name": "Tussnex FM Cold and Sinus",
      "active_ingredients": [
        {
          "name": "ACETAMINOPHEN",
          "strength": "650 mg/20mL"
        },
        {
          "name": "GUAIFENESIN",
          "strength": "400 mg/20mL"
        },
        {
          "name": "PHENYLEPHRINE HYDROCHLORIDE",
          "strength": "10 mg/20mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "53041-616-58",
          "description": "177 mL in 1 BOTTLE (53041-616-58)",
          "marketing_start_date": "20121201",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Guardian Drug Company"
        ],
        "rxcui": [
          "1116568"
        ],
        "spl_set_id": [
          "04c6bb6a-d2f8-4322-afba-e240e8090176"
        ],
        "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": [
          "362O9ITL9D",
          "495W7451VQ",
          "04JA59TNSJ"
        ]
      },
      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "LIQUID",
      "spl_id": "3e372558-1578-4c25-962a-43af6b54de75",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20121201",
      "product_id": "53041-616_3e372558-1578-4c25-962a-43af6b54de75",
      "application_number": "M012",
      "brand_name_base": "Tussnex FM Cold and Sinus",
      "pharm_class": [
        "Adrenergic alpha1-Agonists [MoA]",
        "Decreased Respiratory Secretion Viscosity [PE]",
        "Expectorant [EPC]",
        "Increased Respiratory Secretions [PE]",
        "alpha-1 Adrenergic Agonist [EPC]"
      ]
    }
  ]
}