<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
35916-0185-3
</NDCCode>
<PackageDescription>
2 POUCH in 1 BOX (35916-0185-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH
</PackageDescription>
<NDC11Code>
35916-0185-03
</NDC11Code>
<ProductNDC>
35916-0185
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Acetaminophen, Dextromethorphan Hbr And Doxylamine Succinate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Acetaminophen, Dextromethorphan Hbr And Doxylamine Succinate
</NonProprietaryName>
<DosageFormName>
CAPSULE, LIQUID FILLED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250517
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M012
</ApplicationNumber>
<LabelerName>
Softgel Healthcare Private Limited
</LabelerName>
<SubstanceName>
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
</SubstanceName>
<StrengthNumber>
325; 10; 6.25
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250925
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>