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