<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
58602-508-16
</NDCCode>
<PackageDescription>
355 mL in 1 BOTTLE (58602-508-16)
</PackageDescription>
<NDC11Code>
58602-0508-16
</NDC11Code>
<ProductNDC>
58602-508
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Cold And Flu Nighttime Relief
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Acetaminophen, Doxylamine Succinate, And Dextromethorphan Hbr Solution
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20181008
</StartMarketingDate>
<EndMarketingDate>
20211001
</EndMarketingDate>
<MarketingCategoryName>
OTC MONOGRAPH FINAL
</MarketingCategoryName>
<ApplicationNumber>
part341
</ApplicationNumber>
<LabelerName>
Aurohealth LLC
</LabelerName>
<SubstanceName>
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
</SubstanceName>
<StrengthNumber>
650; 30; 12.5
</StrengthNumber>
<StrengthUnit>
mg/30mL; mg/30mL; mg/30mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2021-10-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20181008
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20211001
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>