<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85966-005-01
</NDCCode>
<PackageDescription>
3 BOTTLE in 1 BOX (85966-005-01) / 5 mL in 1 BOTTLE
</PackageDescription>
<NDC11Code>
85966-0005-01
</NDC11Code>
<ProductNDC>
85966-005
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Nail Fungus Treatment Pen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Undecylenic Acid, Tolnaftate
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250929
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M005
</ApplicationNumber>
<LabelerName>
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
</LabelerName>
<SubstanceName>
TOLNAFTATE; UNDECYLENIC ACID
</SubstanceName>
<StrengthNumber>
1; 25
</StrengthNumber>
<StrengthUnit>
g/100mL; g/100mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-09-30
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250929
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>