<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82645-097-90
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 CARTON (82645-097-90) / 15 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
82645-0097-90
</NDC11Code>
<ProductNDC>
82645-097
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Freskaro Earwax Removal Aid
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Carbamide Peroxide 6.50% Kit
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
AURICULAR (OTIC)
</RouteName>
<StartMarketingDate>
20260413
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M014
</ApplicationNumber>
<LabelerName>
Pharma Nobis, LLC
</LabelerName>
<SubstanceName>
CARBAMIDE PEROXIDE
</SubstanceName>
<StrengthNumber>
6.5
</StrengthNumber>
<StrengthUnit>
g/100mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-04-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260413
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>