<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85424-004-01
</NDCCode>
<PackageDescription>
2 g in 1 PACKAGE (85424-004-01)
</PackageDescription>
<NDC11Code>
85424-0004-01
</NDC11Code>
<ProductNDC>
85424-004
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Roycederm Tea Tree Oil Antifungal Soap.
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Tea Tree Oil Antifungal Soap
</NonProprietaryName>
<DosageFormName>
SOAP
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250806
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M005
</ApplicationNumber>
<LabelerName>
RoyceDerm LLC
</LabelerName>
<SubstanceName>
CLOTRIMAZOLE
</SubstanceName>
<StrengthNumber>
2.32
</StrengthNumber>
<StrengthUnit>
g/232g
</StrengthUnit>
<Pharm_Classes>
Azole Antifungal [EPC], Azoles [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-08-06
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250806
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>