{
"NDC": {
"NDCCode": "57237-360-12",
"PackageDescription": "118 mL in 1 BOTTLE (57237-360-12) ",
"NDC11Code": "57237-0360-12",
"ProductNDC": "57237-360",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucolyte",
"ProprietaryNameSuffix": "Dm",
"NonProprietaryName": "Guaifenesin, Dextromethorphan Hbr",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20251222",
"EndMarketingDate": null,
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "10; 100",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "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]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251222",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}