<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68071-4322-6
</NDCCode>
<PackageDescription>
177 mL in 1 BOTTLE (68071-4322-6)
</PackageDescription>
<NDC11Code>
68071-4322-06
</NDC11Code>
<ProductNDC>
68071-4322
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Calamine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ferric Oxide Red
</NonProprietaryName>
<DosageFormName>
LOTION
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20130107
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M016
</ApplicationNumber>
<LabelerName>
NuCare Pharmaceuticals,Inc.
</LabelerName>
<SubstanceName>
FERRIC OXIDE RED; ZINC OXIDE
</SubstanceName>
<StrengthNumber>
8; 8
</StrengthNumber>
<StrengthUnit>
g/mL; mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-07-09
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20180308
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>