Home NDC 10237-889 Orajel 4X Medicated Toothache and Gum PM Cream
Product NDC 10237-889
11-digit product format 102370889
Labeler code 10237
Product ID 10237-889_5a1cdaf4-3389-280c-e063-6294a90ac70f
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride
Dosage form CREAM
Route TOPICAL
Labeler Church & Dwight Co., Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-31
Substance BENZOCAINE; BENZALKONIUM CHLORIDE; ZINC CHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength 200; .2; 1.5; 2.6 mg/g; mg/g; mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Orajel 4X Medicated Toothache and Gum PM Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g BENZALKONIUM CHLORIDE .2 mg/g ZINC CHLORIDE 1.5 mg/g MENTHOL, UNSPECIFIED FORM 2.6 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2751338 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 15 of 41 · 818 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10237-889-25 10237088925 1 TUBE in 1 CARTON (10237-889-25) / 7 g in 1 TUBE 1 tube 2026-08-31 No No Current