<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
52083-714-01
</NDCCode>
<PackageDescription>
30 mL in 1 BOTTLE (52083-714-01)
</PackageDescription>
<NDC11Code>
52083-0714-01
</NDC11Code>
<ProductNDC>
52083-714
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Gumsol
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Benzocaine, Zinc Chloride
</NonProprietaryName>
<DosageFormName>
SPRAY
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20140228
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M022
</ApplicationNumber>
<LabelerName>
Kramer Novis
</LabelerName>
<SubstanceName>
BENZOCAINE; ZINC CHLORIDE
</SubstanceName>
<StrengthNumber>
1.5; .03
</StrengthNumber>
<StrengthUnit>
g/30mL; g/30mL
</StrengthUnit>
<Pharm_Classes>
Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-21
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20140228
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>