<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85237-1960-5
</NDCCode>
<PackageDescription>
30 POUCH in 1 CARTON (85237-1960-5) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0)
</PackageDescription>
<NDC11Code>
85237-1960-05
</NDC11Code>
<ProductNDC>
85237-1960
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Benadryl
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Diphenhydramine Hydrochloride
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20080901
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M012
</ApplicationNumber>
<LabelerName>
Select Consumer Group
</LabelerName>
<SubstanceName>
DIPHENHYDRAMINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
25
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-07-06
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20120604
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>