<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
48878-4061-3
</NDCCode>
<PackageDescription>
1 TUBE in 1 BOX (48878-4061-3) / 121.9 g in 1 TUBE
</PackageDescription>
<NDC11Code>
48878-4061-03
</NDC11Code>
<ProductNDC>
48878-4061
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Omni
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Stannous Fluoride
</NonProprietaryName>
<DosageFormName>
GEL
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
19980201
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M021
</ApplicationNumber>
<LabelerName>
Solventum US LLC
</LabelerName>
<SubstanceName>
STANNOUS FLUORIDE
</SubstanceName>
<StrengthNumber>
.969
</StrengthNumber>
<StrengthUnit>
mg/g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-08-08
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
19980201
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>