<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0904-7301-86
</NDCCode>
<PackageDescription>
25 POUCH in 1 PACKAGE (0904-7301-86) / 1 APPLICATOR in 1 POUCH (0904-7301-65) / .5 mL in 1 APPLICATOR
</PackageDescription>
<NDC11Code>
00904-7301-86
</NDC11Code>
<ProductNDC>
0904-7301
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Benzocaine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Topical Anesthetic
</NonProprietaryName>
<DosageFormName>
SPRAY
</DosageFormName>
<RouteName>
DENTAL; PERIODONTAL
</RouteName>
<StartMarketingDate>
20240713
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M022
</ApplicationNumber>
<LabelerName>
MAJOR� PHARMACEUTICALS
</LabelerName>
<SubstanceName>
BENZOCAINE
</SubstanceName>
<StrengthNumber>
200
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2025-09-25
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240713
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>