<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
52412-300-10
</NDCCode>
<PackageDescription>
1 BOTTLE, WITH APPLICATOR in 1 CARTON (52412-300-10) > 50 mL in 1 BOTTLE, WITH APPLICATOR
</PackageDescription>
<NDC11Code>
52412-0300-10
</NDC11Code>
<ProductNDC>
52412-300
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Fire Out
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Benzocaine And Menthol
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20160215
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH NOT FINAL
</MarketingCategoryName>
<ApplicationNumber>
part348
</ApplicationNumber>
<LabelerName>
Randob Ltd.
</LabelerName>
<SubstanceName>
BENZOCAINE; MENTHOL, UNSPECIFIED FORM
</SubstanceName>
<StrengthNumber>
200; 10
</StrengthNumber>
<StrengthUnit>
mg/mL; mg/mL
</StrengthUnit>
<Pharm_Classes>
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2019-04-17
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20160215
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>