<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
55715-008-02
</NDCCode>
<PackageDescription>
59 g in 1 BOTTLE, PLASTIC (55715-008-02)
</PackageDescription>
<NDC11Code>
55715-0008-02
</NDC11Code>
<ProductNDC>
55715-008
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Zpol Ultra
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Menthol, Methyl Salicylate
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250401
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M017
</ApplicationNumber>
<LabelerName>
Laboratorios Zepol S.A.
</LabelerName>
<SubstanceName>
MENTHOL; METHYL SALICYLATE
</SubstanceName>
<StrengthNumber>
2.84; 18.24
</StrengthNumber>
<StrengthUnit>
g/100g; g/100g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-04-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250401
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>