{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "84379-444",
      "generic_name": "acetaminophen, dextromethorphan HBr, Doxylamine Succinate",
      "labeler_name": "Rnv LLC",
      "brand_name": "XL-3 Night Time",
      "active_ingredients": [
        {
          "name": "DOXYLAMINE SUCCINATE",
          "strength": "12.5 mg/30mL"
        },
        {
          "name": "ACETAMINOPHEN",
          "strength": "650 mg/30mL"
        },
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "30 mg/30mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "84379-444-06",
          "description": "177 mL in 1 BOTTLE (84379-444-06)",
          "marketing_start_date": "20241201",
          "sample": false
        },
        {
          "package_ndc": "84379-444-12",
          "description": "354 mL in 1 BOTTLE (84379-444-12)",
          "marketing_start_date": "20241201",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Rnv LLC"
        ],
        "rxcui": [
          "1043400"
        ],
        "spl_set_id": [
          "03210929-331e-462d-b566-4e1865f52246"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0645981000351",
          "0645981000290"
        ],
        "unii": [
          "V9BI9B5YI2",
          "362O9ITL9D",
          "9D2RTI9KYH"
        ]
      },
      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "LIQUID",
      "spl_id": "49634dc2-a45b-f42b-e063-6294a90ade9c",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20241201",
      "product_id": "84379-444_49634dc2-a45b-f42b-e063-6294a90ade9c",
      "application_number": "M012",
      "brand_name_base": "XL-3 Night Time",
      "pharm_class": [
        "Antihistamine [EPC]",
        "Histamine Receptor Antagonists [MoA]",
        "Sigma-1 Agonist [EPC]",
        "Sigma-1 Receptor Agonists [MoA]",
        "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]",
        "Uncompetitive NMDA Receptor Antagonists [MoA]"
      ]
    }
  ]
}