{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
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        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20181101",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA209692",
      "sponsor_name": "AMNEAL PHARMS",
      "openfda": {
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          "MUCUS RELIEF DM",
          "MUCUS RELIEF DM EXTENDED RELEASE CAPLETS MAXIMUM STRENGTH",
          "MUCUS RELIEF DM EXTENDED RELEASE CAPLETS",
          "GUAIFENESIN AND DEXTROMETHORPHAN HBR",
          "MAXIMUM STRENGTH GUAIFENESIN DM",
          "MUCUS RELIEF DM MAXIMUM STRENGTH"
        ],
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          "GUAIFENESIN, DEXTROMETHORPHAN HBR",
          "GUAIFENESIN AND DEXTROMETHORPHAN HBR"
        ],
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          "CVS Pharmacy",
          "QUALITY CHOICE (Chain Drug Marketing Association)",
          "Rugby Laboratories",
          "Amneal Pharmaceuticals LLC",
          "Care One (Retail Business Services, LLC.)",
          "Best Choice (Valu Merchandisers Company)",
          "Chain Drug Consortium, LLC",
          "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)",
          "P & L Development, LLC",
          "Rite Aid Corporation",
          "WinCo Foods, LLC"
        ],
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        ],
        "product_type": [
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        ],
        "nui": [
          "N0000193956",
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          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "495W7451VQ",
          "9D2RTI9KYH"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE",
          "active_ingredients": [
            {
              "name": "DEXTROMETHORPHAN HYDROBROMIDE",
              "strength": "60MG"
            },
            {
              "name": "GUAIFENESIN",
              "strength": "1.2GM"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        },
        {
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          "reference_drug": "No",
          "brand_name": "GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE",
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              "name": "DEXTROMETHORPHAN HYDROBROMIDE",
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            {
              "name": "GUAIFENESIN",
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          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
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      ]
    }
  ]
}