Home NDC 10237-783 Orajel 3X Medicated For All Mouth Sores
Product NDC 10237-783
11-digit product format 102370783
Labeler code 10237
Product ID 10237-783_45c2f5a1-7e8a-1fbd-e063-6394a90ab88f
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine, Menthol, Zinc Chloride
Dosage form GEL
Route TOPICAL
Labeler Church & Dwight Co., Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-01
Substance BENZOCAINE; MENTHOL; ZINC CHLORIDE
Active strength 200; 1; 1.5 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 2026-12-31
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 3X Medicated For All Mouth Sores
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g MENTHOL 1 mg/g ZINC CHLORIDE 1.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup L7T10EIP3A Internal UNII lookup 86Q357L16B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2266762 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10237-783-12 Orajel 3X Medicated For All Mouth Sores 1 in 1 CARTON GEL 1 5 10237-783-12 Orajel 3X Medicated For All Mouth Sores 3.5 g in 1 TUBE GEL 3.5 5 10237-783-18 Orajel 3X Medicated For All Mouth Sores 1 in 1 CARTON GEL 1 5 10237-783-18 Orajel 3X Medicated For All Mouth Sores 5.1 g in 1 TUBE GEL 5.1 5 10237-783-42 Orajel 3X Medicated For All Mouth Sores 1 in 1 CARTON GEL 1 5 10237-783-42 Orajel 3X Medicated For All Mouth Sores 11.9 g in 1 TUBE GEL 11.9 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-783 ORAJEL 3X MEDICATED FOR ALL MOUTH SORES (BENZOCAINE, MENTHOL, ZINC CHLORIDE) GEL [CHURCH & DWIGHT CO., INC.] 4 Current NDC, Legacy NDC, 6 package rows 20241129_99b589ac-9833-fb60-e053-2995a90a0935.zip
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 14 of 41 · 818 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10237-783-12 10237078312 1 TUBE in 1 CARTON (10237-783-12) / 3.5 g in 1 TUBE 1 tube 2019-11-01 0000-00-00 No No Current 10237-783-18 10237078318 1 TUBE in 1 CARTON (10237-783-18) / 5.1 g in 1 TUBE 1 tube 2019-11-01 0000-00-00 No No Current 10237-783-42 10237078342 1 TUBE in 1 CARTON (10237-783-42) / 11.9 g in 1 TUBE 1 tube 2019-11-01 0000-00-00 No No Current