{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "58593-276",
      "generic_name": "Dextromethorphan HBr, Guaifenesin",
      "labeler_name": "Efficient Laboratories Inc",
      "brand_name": "Rompe Pechito DM for Kids",
      "brand_name_suffix": "DM for Kids",
      "active_ingredients": [
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "5 mg/2.5mL"
        },
        {
          "name": "GUAIFENESIN",
          "strength": "50 mg/2.5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "58593-276-04",
          "description": "118 mL in 1 BOTTLE (58593-276-04)",
          "marketing_start_date": "20230801",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Efficient Laboratories Inc"
        ],
        "rxcui": [
          "996520"
        ],
        "spl_set_id": [
          "004d12e1-6e3d-84c8-e063-6394a90aa653"
        ],
        "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": "411e99da-2482-40c7-e063-6394a90aaf80",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20230801",
      "product_id": "58593-276_411e99da-2482-40c7-e063-6394a90aaf80",
      "application_number": "M012",
      "brand_name_base": "Rompe Pechito",
      "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]"
      ]
    }
  ]
}