{
"NDC": {
"NDCCode": "72854-001-50",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (72854-001-50) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "72854-0001-50",
"ProductNDC": "72854-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex",
"ProprietaryNameSuffix": "12hr Cold And Fever Multi-symptom",
"NonProprietaryName": "Naproxen Sodium, Dextromethorphan Hydrobromide, Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217338",
"LabelerName": "Reckitt Benckiser LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM",
"StrengthNumber": "30; 600; 110",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Nonsteroidal Anti-inflammatory Drug [EPC], 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": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}