<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
87351-761-10
</NDCCode>
<PackageDescription>
1 TUBE in 1 PACKAGE (87351-761-10) / 10 mL in 1 TUBE
</PackageDescription>
<NDC11Code>
87351-0761-10
</NDC11Code>
<ProductNDC>
87351-761
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Ora Yogu 4x Medicated Tooth And Gum Pain Reliever
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Medicated Tooth And Gum Pain Reliever
</NonProprietaryName>
<DosageFormName>
GEL
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260415
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M022
</ApplicationNumber>
<LabelerName>
Kungpo Health Care & Herbal Center Inc
</LabelerName>
<SubstanceName>
BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL; ZINC CHLORIDE
</SubstanceName>
<StrengthNumber>
.13; 20; .26; .15
</StrengthNumber>
<StrengthUnit>
g/100mL; g/100mL; g/100mL; g/100mL
</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>
2026-04-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260415
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>