<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
42086-052-02
</NDCCode>
<PackageDescription>
720 TUBE in 1 PACKAGE (42086-052-02) / 17 g in 1 TUBE
</PackageDescription>
<NDC11Code>
42086-0052-02
</NDC11Code>
<ProductNDC>
42086-052
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Charm Tex Fluoride Gel
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sodium Fluoride
</NonProprietaryName>
<DosageFormName>
PASTE, DENTIFRICE
</DosageFormName>
<RouteName>
DENTAL
</RouteName>
<StartMarketingDate>
20260531
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M017
</ApplicationNumber>
<LabelerName>
Jiangsu Gold Worldworks Household Chemicals Co., Ltd.
</LabelerName>
<SubstanceName>
SODIUM FLUORIDE
</SubstanceName>
<StrengthNumber>
.1
</StrengthNumber>
<StrengthUnit>
g/100g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-06-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260531
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>