<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
67777-241-04
</NDCCode>
<PackageDescription>
36 JAR in 1 CASE (67777-241-04) / 71 g in 1 JAR (67777-241-03)
</PackageDescription>
<NDC11Code>
67777-0241-04
</NDC11Code>
<ProductNDC>
67777-241
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Calasoothe
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Calamine, Menthol, And Zinc Oxide
</NonProprietaryName>
<DosageFormName>
OINTMENT
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260629
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M015
</ApplicationNumber>
<LabelerName>
Dynarex Corporation
</LabelerName>
<SubstanceName>
MENTHOL; ZINC OXIDE; FERRIC OXIDE RED
</SubstanceName>
<StrengthNumber>
5; .44; 20.625
</StrengthNumber>
<StrengthUnit>
g/100g; g/100g; g/100g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-07-09
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260629
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>