{
  "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": "50991-271",
      "generic_name": "DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR",
      "labeler_name": "POLY PHARMACEUTICALS, INC.",
      "brand_name": "POLY-HIST DM",
      "active_ingredients": [
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "10 mg/5mL"
        },
        {
          "name": "DEXCHLORPHENIRAMINE MALEATE",
          "strength": "1 mg/5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "50991-271-15",
          "description": "15 mL in 1 BOTTLE (50991-271-15)",
          "marketing_start_date": "20260423",
          "sample": false
        },
        {
          "package_ndc": "50991-271-16",
          "description": "473 mL in 1 BOTTLE (50991-271-16)",
          "marketing_start_date": "20260423",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "POLY PHARMACEUTICALS, INC."
        ],
        "rxcui": [
          "2741371"
        ],
        "spl_set_id": [
          "5025c99f-b946-e2e0-e063-6394a90a13fb"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0350991271164"
        ],
        "unii": [
          "9D2RTI9KYH",
          "B10YD955QW"
        ]
      },
      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "LIQUID",
      "spl_id": "5025c99f-b947-e2e0-e063-6394a90a13fb",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20260423",
      "product_id": "50991-271_5025c99f-b947-e2e0-e063-6394a90a13fb",
      "application_number": "M012",
      "brand_name_base": "POLY-HIST DM",
      "pharm_class": [
        "Sigma-1 Agonist [EPC]",
        "Sigma-1 Receptor Agonists [MoA]",
        "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]",
        "Uncompetitive NMDA Receptor Antagonists [MoA]"
      ]
    }
  ]
}