Home NDC 10237-761 Orajel Cold Sore Moisturelock
Product NDC 10237-761
11-digit product format 102370761
Labeler code 10237
Product ID 10237-761_27d37e6f-4fd8-ce0e-e063-6394a90ad259
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form CREAM
Route TOPICAL
Labeler Church & Dwight Co., Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-07-01
Substance BENZOCAINE; ALLANTOIN; CAMPHOR (NATURAL); DIMETHICONE; MENTHOL; PETROLATUM
Active strength 200; 5; 30; 20; 10; 640 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Skin Barrier Activity [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 Cold Sore Moisturelock
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g ALLANTOIN 5 mg/g CAMPHOR (NATURAL) 30 mg/g DIMETHICONE 20 mg/g MENTHOL 10 mg/g PETROLATUM 640 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 6 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2257305 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 10237-761-01 Orajel Cold Sore Moisturelock 3 g in 1 TUBE CREAM 3 8 10237-761-01 Orajel Cold Sore Moisturelock 1 in 1 CARTON CREAM 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-761 ORAJEL COLD SORE MOISTURELOCK (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.] 8 Current NDC, Legacy NDC, 2 package rows 20241127_3761c7b3-053b-0f50-e054-00144ff88e88.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 53 of 68 · 1,357 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 10237-761-01 10237076101 1 TUBE in 1 CARTON (10237-761-01) / 3 g in 1 TUBE 1 tube 2016-07-01 0000-00-00 No No Current