{
"NDC": {
"NDCCode": "87078-972-32",
"PackageDescription": "12 POUCH in 1 CARTON (87078-972-32) / 15 mL in 1 POUCH (87078-972-03) ",
"NDC11Code": "87078-0972-32",
"ProductNDC": "87078-972",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Onessip Adult Daytime Severe Cold And Flu",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20251215",
"EndMarketingDate": null,
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "MEDWISE LIFESCIENCES INC.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 400; 10",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL; mg/15mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251215",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}