<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
51862-771-30
</NDCCode>
<PackageDescription>
1 BOTTLE, PUMP in 1 CARTON (51862-771-30) / 30 g in 1 BOTTLE, PUMP
</PackageDescription>
<NDC11Code>
51862-0771-30
</NDC11Code>
<ProductNDC>
51862-771
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Twyneo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Benzoyl Peroxide And Tretinoin
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250801
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA214902
</ApplicationNumber>
<LabelerName>
Mayne Pharma Commercial LLC
</LabelerName>
<SubstanceName>
BENZOYL PEROXIDE; TRETINOIN
</SubstanceName>
<StrengthNumber>
30; 1
</StrengthNumber>
<StrengthUnit>
mg/g; mg/g
</StrengthUnit>
<Pharm_Classes>
Retinoid [EPC], Retinoids [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-08-14
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250801
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>