<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61577-3440-2
</NDCCode>
<PackageDescription>
1 g in 1 PACKET (61577-3440-2)
</PackageDescription>
<NDC11Code>
61577-3440-02
</NDC11Code>
<ProductNDC>
61577-3440
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Sombra Max
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sombra Max
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260101
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M017
</ApplicationNumber>
<LabelerName>
Sombra Cosmetics Inc.
</LabelerName>
<SubstanceName>
CAMPHOR (SYNTHETIC); CAPSAICIN; HISTAMINE DIHYDROCHLORIDE; MENTHOL GLUCURONIDE; METHYL SALICYLATE
</SubstanceName>
<StrengthNumber>
3; .025; .025; 6; 12
</StrengthNumber>
<StrengthUnit>
g/100g; g/100g; g/100g; g/100g; g/100g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260101
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>