<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
10237-889-25
</NDCCode>
<PackageDescription>
1 TUBE in 1 CARTON (10237-889-25) / 7 g in 1 TUBE
</PackageDescription>
<NDC11Code>
10237-0889-25
</NDC11Code>
<ProductNDC>
10237-889
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Orajel 4x Medicated Toothache And Gum Pm Cream
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Benzalkonium Chloride, Benzocaine, Menthol, Zinc Chloride
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260831
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M022
</ApplicationNumber>
<LabelerName>
Church & Dwight Co., Inc.
</LabelerName>
<SubstanceName>
BENZOCAINE; BENZALKONIUM CHLORIDE; ZINC CHLORIDE; MENTHOL, UNSPECIFIED FORM
</SubstanceName>
<StrengthNumber>
200; .2; 1.5; 2.6
</StrengthNumber>
<StrengthUnit>
mg/g; mg/g; mg/g; mg/g
</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>
2026-08-31
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260831
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>