<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
87078-131-52
</NDCCode>
<PackageDescription>
12 POUCH in 1 CARTON (87078-131-52) / 5 mL in 1 POUCH (87078-131-05)
</PackageDescription>
<NDC11Code>
87078-0131-52
</NDC11Code>
<ProductNDC>
87078-131
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Onessip Acetaminophen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Acetaminophen
</NonProprietaryName>
<DosageFormName>
SUSPENSION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250922
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M013
</ApplicationNumber>
<LabelerName>
MEDWISE LIFESCIENCES INC.
</LabelerName>
<SubstanceName>
ACETAMINOPHEN
</SubstanceName>
<StrengthNumber>
160
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-13
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250922
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>