<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72854-223-20
</NDCCode>
<PackageDescription>
2 BLISTER PACK in 1 CARTON (72854-223-20) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
72854-0223-20
</NDC11Code>
<ProductNDC>
72854-223
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Mucinex
</ProprietaryName>
<ProprietaryNameSuffix>
Ds 12hr Cold, Fever And Sinus
</ProprietaryNameSuffix>
<NonProprietaryName>
Naproxen Sodium, Pseudoephedrine Hydrochloride
</NonProprietaryName>
<DosageFormName>
TABLET, EXTENDED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260701
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA076518
</ApplicationNumber>
<LabelerName>
Reckitt Benckiser LLC
</LabelerName>
<SubstanceName>
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
220; 120
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-07-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260701
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>