{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "58552-133",
      "generic_name": "Dextromethorphan hydrobromide, Guaifenesin",
      "labeler_name": "Gil Pharmaceutical Corp",
      "brand_name": "Giltuss Childrens Cough and Chest Congestion",
      "active_ingredients": [
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "10 mg/5mL"
        },
        {
          "name": "GUAIFENESIN",
          "strength": "100 mg/5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "58552-133-04",
          "description": "1 BOTTLE in 1 CARTON (58552-133-04)  / 118 mL in 1 BOTTLE",
          "marketing_start_date": "20181002",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Gil Pharmaceutical Corp"
        ],
        "rxcui": [
          "996520"
        ],
        "spl_set_id": [
          "852d5f01-9289-5515-e053-2a91aa0acf32"
        ],
        "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": "SOLUTION",
      "spl_id": "40b83871-7eac-3d44-e063-6394a90a2b29",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20181002",
      "product_id": "58552-133_40b83871-7eac-3d44-e063-6394a90a2b29",
      "application_number": "M012",
      "brand_name_base": "Giltuss Childrens Cough and Chest Congestion",
      "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]"
      ]
    }
  ]
}