<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
73282-2524-2
</NDCCode>
<PackageDescription>
18 VIAL, SINGLE-DOSE in 1 POUCH (73282-2524-2) / 10 mL in 1 VIAL, SINGLE-DOSE (73282-2524-1)
</PackageDescription>
<NDC11Code>
73282-2524-02
</NDC11Code>
<ProductNDC>
73282-2524
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Calmco
</ProprietaryName>
<ProprietaryNameSuffix>
Allergy Relief
</ProprietaryNameSuffix>
<NonProprietaryName>
Diphenhydramine Hcl
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260101
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M012
</ApplicationNumber>
<LabelerName>
CalmCo LLC
</LabelerName>
<SubstanceName>
DIPHENHYDRAMINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
25
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes>
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260101
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>