<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
80684-210-01
</NDCCode>
<PackageDescription>
26 g in 1 TUBE (80684-210-01)
</PackageDescription>
<NDC11Code>
80684-0210-01
</NDC11Code>
<ProductNDC>
80684-210
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Thera Plus Hemorrhoidal
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Glycerin, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, White Petrolatum
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260312
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M015
</ApplicationNumber>
<LabelerName>
Fourstar Group USA, Inc.
</LabelerName>
<SubstanceName>
GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; WHITE PETROLATUM
</SubstanceName>
<StrengthNumber>
144; 2.5; 10; 150
</StrengthNumber>
<StrengthUnit>
mg/g; mg/g; mg/g; mg/g
</StrengthUnit>
<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]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-04-09
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260312
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>