<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0299-5945-30
</NDCCode>
<PackageDescription>
1 BOTTLE, PUMP in 1 BOX (0299-5945-30) / 30 g in 1 BOTTLE, PUMP
</PackageDescription>
<NDC11Code>
00299-5945-30
</NDC11Code>
<ProductNDC>
0299-5945
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Twyneo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Tretinoin And Benzoyl Peroxide
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20220315
</StartMarketingDate>
<EndMarketingDate>
20261031
</EndMarketingDate>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA214902
</ApplicationNumber>
<LabelerName>
Galderma Laboratories, L.P.
</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>
2025-07-07
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20220315
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20261031
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>