<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84763-008-01
</NDCCode>
<PackageDescription>
8 TUBE, WITH APPLICATOR in 1 BOX (84763-008-01) / 24 mL in 1 TUBE, WITH APPLICATOR
</PackageDescription>
<NDC11Code>
84763-0008-01
</NDC11Code>
<ProductNDC>
84763-008
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Nail Repair Pen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Undecylenic Acid
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20251209
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M005
</ApplicationNumber>
<LabelerName>
Yunqi Cosmetics (Shenzhen) Co., Ltd
</LabelerName>
<SubstanceName>
UNDECYLENIC ACID
</SubstanceName>
<StrengthNumber>
.25
</StrengthNumber>
<StrengthUnit>
g/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251209
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>