<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85786-602-24
</NDCCode>
<PackageDescription>
2 BLISTER PACK in 1 CARTON (85786-602-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
85786-0602-24
</NDC11Code>
<ProductNDC>
85786-602
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Dr. Simi Nighttime Cold And Flu
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Acetaminophen 325 Mg, Dextromethorphan Hbr 15 Mg, Doxylamine Succinate 6.25 Mg
</NonProprietaryName>
<DosageFormName>
CAPSULE, LIQUID FILLED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260330
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M012
</ApplicationNumber>
<LabelerName>
Farmacias De Similares TX LLC
</LabelerName>
<SubstanceName>
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
</SubstanceName>
<StrengthNumber>
325; 15; 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>
2026-04-07
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260330
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>