<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82876-989-01
</NDCCode>
<PackageDescription>
4.455 g in 1 TUBE (82876-989-01)
</PackageDescription>
<NDC11Code>
82876-0989-01
</NDC11Code>
<ProductNDC>
82876-989
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Earthmed Lip Balm Unflavored
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Allantoin
</NonProprietaryName>
<DosageFormName>
SALVE
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250805
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M016
</ApplicationNumber>
<LabelerName>
Earthmed LLC
</LabelerName>
<SubstanceName>
ALLANTOIN
</SubstanceName>
<StrengthNumber>
.045
</StrengthNumber>
<StrengthUnit>
g/4.455g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-08-06
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250805
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>