<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
75712-542-38
</NDCCode>
<PackageDescription>
296 mL in 1 BOTTLE, PLASTIC (75712-542-38)
</PackageDescription>
<NDC11Code>
75712-0542-38
</NDC11Code>
<ProductNDC>
75712-542
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Cetylpyridinium Chloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Cetylpyridinium Chloride
</NonProprietaryName>
<DosageFormName>
MOUTHWASH
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20261016
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
505G(a)(3)
</ApplicationNumber>
<LabelerName>
Old East Main Co.
</LabelerName>
<SubstanceName>
CETYLPYRIDINIUM CHLORIDE
</SubstanceName>
<StrengthNumber>
.5
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-10-20
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20261016
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>