<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
50269-158-01
</NDCCode>
<PackageDescription>
25 POUCH in 1 BOX (50269-158-01) / 2 TABLET, FILM COATED in 1 POUCH
</PackageDescription>
<NDC11Code>
50269-0158-01
</NDC11Code>
<ProductNDC>
50269-158
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Excedrin Extra Strength Headache
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Acetaminophen, Aspirin, Caffeine
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20240101
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA020802
</ApplicationNumber>
<LabelerName>
JC World Bell Wholesale Co., Inc
</LabelerName>
<SubstanceName>
ACETAMINOPHEN; ASPIRIN; CAFFEINE
</SubstanceName>
<StrengthNumber>
250; 250; 65
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-12-27
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240101
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>