<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85808-615-00
</NDCCode>
<PackageDescription>
1 TUBE in 1 BOX (85808-615-00) / 100 mL in 1 TUBE
</PackageDescription>
<NDC11Code>
85808-0615-00
</NDC11Code>
<ProductNDC>
85808-615
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Pt Elite Premium Pain Relief
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Capsaicin, Menthol
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250509
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M017
</ApplicationNumber>
<LabelerName>
PT ELITE PRODUCTS LLC
</LabelerName>
<SubstanceName>
CAPSAICIN; MENTHOL
</SubstanceName>
<StrengthNumber>
.35; 40
</StrengthNumber>
<StrengthUnit>
mg/mL; mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-07-25
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250509
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>