<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70677-1199-1
</NDCCode>
<PackageDescription>
177 mL in 1 BOTTLE, PLASTIC (70677-1199-1)
</PackageDescription>
<NDC11Code>
70677-1199-01
</NDC11Code>
<ProductNDC>
70677-1199
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Foster And Thrive Caldyphen Clear
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Pramoxine Hydrochloride And Zinc Acetate
</NonProprietaryName>
<DosageFormName>
LOTION
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20241218
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M016
</ApplicationNumber>
<LabelerName>
Strategic Sourcing Services, LLC
</LabelerName>
<SubstanceName>
PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
</SubstanceName>
<StrengthNumber>
10; 1
</StrengthNumber>
<StrengthUnit>
mg/mL; mg/mL
</StrengthUnit>
<Pharm_Classes>
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-12-27
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241218
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>