{
"NDC": {
"NDCCode": "80684-210-01",
"PackageDescription": "26 g in 1 TUBE (80684-210-01) ",
"NDC11Code": "80684-0210-01",
"ProductNDC": "80684-210",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thera Plus Hemorrhoidal",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Glycerin, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, White Petrolatum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260312",
"EndMarketingDate": null,
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "Fourstar Group USA, Inc.",
"SubstanceName": "GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; WHITE PETROLATUM",
"StrengthNumber": "144; 2.5; 10; 150",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260312",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}