<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84035-012-20
</NDCCode>
<PackageDescription>
1000 mL in 1 BOTTLE (84035-012-20)
</PackageDescription>
<NDC11Code>
84035-0012-20
</NDC11Code>
<ProductNDC>
84035-012
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Dentalclean Green Diamond Alcohol Free Mouthwash
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sodium Fluoride 0.05%
</NonProprietaryName>
<DosageFormName>
RINSE
</DosageFormName>
<RouteName>
DENTAL
</RouteName>
<StartMarketingDate>
20250701
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M021
</ApplicationNumber>
<LabelerName>
Rabbit Ind�stria e Com�rcio de Produtos de Higiene Pessoal Ltda
</LabelerName>
<SubstanceName>
SODIUM FLUORIDE
</SubstanceName>
<StrengthNumber>
.2
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-07-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250701
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>