{
  "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": "54859-509",
      "generic_name": "Dextromethorphan HBr, Guaifenesin",
      "labeler_name": "Llorens Pharmaceutical International Division, Inc.",
      "brand_name": "Tusnel Cough Suppressant Expectorant",
      "active_ingredients": [
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "10 mg/5mL"
        },
        {
          "name": "GUAIFENESIN",
          "strength": "100 mg/5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "54859-509-16",
          "description": "473 mL in 1 BOTTLE (54859-509-16)",
          "marketing_start_date": "20220701",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Llorens Pharmaceutical International Division, Inc."
        ],
        "rxcui": [
          "996520"
        ],
        "spl_set_id": [
          "af71cdbc-33d6-4303-b494-d7321721d3be"
        ],
        "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": [
          "9D2RTI9KYH",
          "495W7451VQ"
        ]
      },
      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "LIQUID",
      "spl_id": "4746270d-593c-472a-e063-6294a90ace21",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20190501",
      "product_id": "54859-509_4746270d-593c-472a-e063-6294a90ace21",
      "application_number": "M012",
      "brand_name_base": "Tusnel Cough Suppressant Expectorant",
      "pharm_class": [
        "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]"
      ]
    }
  ]
}