<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85424-007-01
</NDCCode>
<PackageDescription>
2 BOTTLE, PUMP in 1 CARTON (85424-007-01) / 250 mL in 1 BOTTLE, PUMP
</PackageDescription>
<NDC11Code>
85424-0007-01
</NDC11Code>
<ProductNDC>
85424-007
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Roycederm Cooldefense Refreshing Shower Gel
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Tolnaftate 1.0%
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250831
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M005
</ApplicationNumber>
<LabelerName>
RoyceDerm LLC
</LabelerName>
<SubstanceName>
TOLNAFTATE
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
g/100mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-09-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250831
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>