<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
87306-126-01
</NDCCode>
<PackageDescription>
113.4 g in 1 JAR (87306-126-01)
</PackageDescription>
<NDC11Code>
87306-0126-01
</NDC11Code>
<ProductNDC>
87306-126
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Rommy Jean-pierre Llc Anti-fungal Cream
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Miconazole Nitrate Cream
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260208
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M005
</ApplicationNumber>
<LabelerName>
RoMMY Jean-Pierre LLC
</LabelerName>
<SubstanceName>
CAMPHOR (SYNTHETIC); MENTHOL; MICONAZOLE NITRATE; SULFUR
</SubstanceName>
<StrengthNumber>
1; 1; 2; 5
</StrengthNumber>
<StrengthUnit>
g/100g; g/100g; g/100g; g/100g
</StrengthUnit>
<Pharm_Classes>
Azole Antifungal [EPC], Azoles [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-02-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260208
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>