Home NDC 10237-797-12 Orajel for Cold Sores Double Medicated, Cream
Product NDC 10237-797
Requested package NDC 10237-797-12
11-digit product format 102370797
Labeler code 10237
Product ID 10237-797_45382973-75d6-bf98-e063-6294a90a50fc
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine and White Petrolatum
Dosage form CREAM
Route TOPICAL
Labeler Church & Dwight Co., Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-18
Substance BENZOCAINE; PETROLATUM
Active strength 200; 736.4 mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [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 for Cold Sores Double Medicated, Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g PETROLATUM 736.4 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup 4T6H12BN9U Internal UNII 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 10237-797-12 Orajel for Cold Sores Double Medicated, Cream 3.5 g in 1 TUBE CREAM 3.5 5 10237-797-12 Orajel for Cold Sores Double Medicated, Cream 1 in 1 CARTON CREAM 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-797 ORAJEL FOR COLD SORES DOUBLE MEDICATED, CREAM (BENZOCAINE AND WHITE PETROLATUM) CREAM [CHURCH & DWIGHT CO., INC.] 4 Current NDC, Legacy NDC, 2 package rows 20241129_b8699a40-8464-ca02-e053-2995a90a4260.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 77 of 152 · 3,029 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10237-797-12 10237079712 1 TUBE in 1 CARTON (10237-797-12) / 3.5 g in 1 TUBE 1 tube 2021-01-18 0000-00-00 No No Current