<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63615-001-02
</NDCCode>
<PackageDescription>
3800 mL in 1 JUG (63615-001-02)
</PackageDescription>
<NDC11Code>
63615-0001-02
</NDC11Code>
<ProductNDC>
63615-001
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Cavity Protection Fresh Mint Anticavity Mouthwash
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sodium Fluoride
</NonProprietaryName>
<DosageFormName>
MOUTHWASH
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20140523
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M021
</ApplicationNumber>
<LabelerName>
Oxyfresh Worldwide Inc
</LabelerName>
<SubstanceName>
SODIUM FLUORIDE
</SubstanceName>
<StrengthNumber>
.5
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-09-12
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20140523
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20260131
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>