<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85248-165-01
</NDCCode>
<PackageDescription>
3 BOX in 1 BOX (85248-165-01) / 2.5 mL in 1 BOX
</PackageDescription>
<NDC11Code>
85248-0165-01
</NDC11Code>
<ProductNDC>
85248-165
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Serynth Antifungal Nail Treatment Pen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Undecylenic Acid 25% Antifungal Nail Treatment Pen
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260319
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M005
</ApplicationNumber>
<LabelerName>
Jiangxi Yudexi Pharmaceutical Co., LTD
</LabelerName>
<SubstanceName>
UNDECYLENIC ACID
</SubstanceName>
<StrengthNumber>
25
</StrengthNumber>
<StrengthUnit>
g/100mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-03-21
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260319
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>