{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "product_ndc": "49035-044",
      "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
      "labeler_name": "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)",
      "brand_name": "NiteTime Cold and Flu",
      "active_ingredients": [
        {
          "name": "ACETAMINOPHEN",
          "strength": "650 mg/30mL"
        },
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "30 mg/30mL"
        },
        {
          "name": "DOXYLAMINE SUCCINATE",
          "strength": "12.5 mg/30mL"
        }
      ],
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      "packaging": [
        {
          "package_ndc": "49035-044-12",
          "description": "355 mL in 1 BOTTLE, PLASTIC (49035-044-12)",
          "marketing_start_date": "20141231",
          "sample": false
        },
        {
          "package_ndc": "49035-044-24",
          "description": "2 BOTTLE, PLASTIC in 1 PACKAGE (49035-044-24)  / 355 mL in 1 BOTTLE, PLASTIC",
          "marketing_start_date": "20141231",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)"
        ],
        "rxcui": [
          "1043400"
        ],
        "spl_set_id": [
          "7b3c4793-9369-4331-bd5a-40f20b9df2b0"
        ],
        "is_original_packager": [
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        "upc": [
          "0681131036757"
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        "unii": [
          "362O9ITL9D",
          "9D2RTI9KYH",
          "V9BI9B5YI2"
        ]
      },
      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "LIQUID",
      "spl_id": "c89a3a3d-c54f-4577-ba38-61360cc7487f",
      "product_type": "HUMAN OTC DRUG",
      "route": [
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      ],
      "marketing_start_date": "20141231",
      "product_id": "49035-044_c89a3a3d-c54f-4577-ba38-61360cc7487f",
      "application_number": "M012",
      "brand_name_base": "NiteTime Cold and Flu",
      "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]"
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}