<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82645-098-91
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 CARTON (82645-098-91) / 30 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
82645-0098-91
</NDC11Code>
<ProductNDC>
82645-098
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Freskaro Ear Drops For Swimmers
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Freskaro Ear Drops For Swimmers
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
AURICULAR (OTIC)
</RouteName>
<StartMarketingDate>
20260603
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M014
</ApplicationNumber>
<LabelerName>
Pharma Nobis, LLC
</LabelerName>
<SubstanceName>
ISOPROPYL ALCOHOL
</SubstanceName>
<StrengthNumber>
950
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-06-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260603
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>