<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
83592-814-04
</NDCCode>
<PackageDescription>
1 TUBE in 1 CARTON (83592-814-04) / 122 g in 1 TUBE
</PackageDescription>
<NDC11Code>
83592-0814-04
</NDC11Code>
<ProductNDC>
83592-814
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Fraiche 5000 Dental Mint
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sodium Fluoride
</NonProprietaryName>
<DosageFormName>
GEL
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20240812
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
True Marker Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
SODIUM FLUORIDE
</SubstanceName>
<StrengthNumber>
1.1
</StrengthNumber>
<StrengthUnit>
g/100g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2026-01-09
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240812
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>