<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82500-010-02
</NDCCode>
<PackageDescription>
30 PACKET in 1 CARTON (82500-010-02) > 11 mL in 1 PACKET (82500-010-01)
</PackageDescription>
<NDC11Code>
82500-0010-02
</NDC11Code>
<ProductNDC>
82500-010
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Hellotis Mouthwash
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sodium Fluoride
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20211201
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH FINAL
</MarketingCategoryName>
<ApplicationNumber>
part355
</ApplicationNumber>
<LabelerName>
iONEBIO INC.
</LabelerName>
<SubstanceName>
SODIUM FLUORIDE
</SubstanceName>
<StrengthNumber>
.0022
</StrengthNumber>
<StrengthUnit>
g/11mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2023-08-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20231231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20211201
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>