Home NDC 10237-797 Orajel for Cold Sores Double Medicated, Cream
Product NDC 10237-797
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 82 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join METHYL SALICYLATE 25% METHYL SALICYLATE Oncora Pharma, LLC 3c4bc55d-6582-3b5e-e063-6394a90a994c 2025-08-13 Warnings Exact identifier application number: M017 Lidocaine 3% LIDOCAINE HCL 3% PureTek Corporation 3bc94d52-fe52-9fd6-e063-6294a90a4340 2025-08-12 Warnings Exact identifier application number: M017 Fast Freeze MENTHOL Natural Essentials Inc. d8c42c8d-6ce0-43bf-b165-41979f3d8f79 2025-08-12 Warnings Exact identifier application number: M017 Careland X-large Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. a6867506-4a46-47b1-b5b6-bfedb59dfde6 2025-08-11 Warnings Exact identifier application number: M017 Dermedial Anti-Ouch MENTHOL Saje Natural Business Inc. 3c194b8f-cfa5-11e3-e063-6394a90a92de 2025-08-11 Warnings Exact identifier application number: M017 Thera Plus Extra Strength Muscle Rub Topical Analgesic MENTHOL FOURSTAR GROUP USA, INC. 8a3b6adf-afbb-4d77-a19b-a6514ebd3b50 2025-08-11 Warnings Exact identifier application number: M017 EARTHS CARE ARTHRITIS CAPSAICIN DLC Laboratories, Inc. 9460674b-057e-40b9-a0f9-ca3d92068d4f 2025-08-11 Warnings Exact identifier application number: M017 LILAS PERIOD MENTHOL Lilas Wellness, Inc. 5ea53b4b-45e6-48a7-8090-09c3a21e7f63 2025-08-11 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel Roll-On LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 31639407-0f11-bde2-e063-6294a90af694 2025-08-10 Warnings Exact identifier application number: M017 Chinese Red Tiger Lidocaine Patches LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 20cd369c-3e98-3d8f-e063-6394a90a0824 2025-08-10 Warnings Exact identifier application number: M017 Treatonic LIDOCAINE PAIN RELIEF LIDOCAINE 4% 100 KARMA INC 3bd66b03-ac82-2d45-e063-6294a90a610a 2025-08-08 Warnings Exact identifier application number: M017 Capsaicin 0.025% CAPSAICIN 0.025% Advanced Rx of Tennessee, LLC 3bdcef94-d06f-9152-e063-6294a90a6072 2025-08-08 Warnings Exact identifier application number: M017 MENTHOL 5% MENTHOL 5% Advanced Rx of Tennessee, LLC 3bdd0c52-29d8-ab67-e063-6294a90a9c45 2025-08-08 Warnings Exact identifier application number: M017 Methyl Salicylate 25% Cream METHYL SALICYLATE Advanced Rx of Tennessee, LLC 3bdd3015-349a-0fac-e063-6394a90afe41 2025-08-08 Warnings Exact identifier application number: M017 LIDOCAINE 4% LIDOCAINE 4% Advanced Rx of Tennessee, LLC 3bdd6b3d-7180-288c-e063-6394a90a1785 2025-08-08 Warnings Exact identifier application number: M017 Good Sense Pain Relief Roll On LIDOCAINE HCL Geiss, Destin & Dunn, Inc 38e76fd6-e5fb-493c-e063-6294a90afed4 2025-08-08 Warnings Exact identifier application number: M017 Aruba Aloe Alcoholada LIDOCAINE HYDROCHLORIDE Aruba Aloe Balm NV f56c62b0-75db-4499-858e-54e10b0e140a 2025-08-07 Warnings Exact identifier application number: M017 SurviveX Hydrocortisone Cream HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. 3bd1da8d-5142-798c-e063-6294a90a7be6 2025-08-07 Warnings Exact identifier application number: M017 Arthcal SOOTHING PAIN RELIEF MASSAGE SOOTHING PAIN RELIEF MASSAGE Beijing JUNGE Technology Co., Ltd. 3524ad62-0ed6-f2e5-e063-6394a90a3283 2025-08-06 Warnings Exact identifier application number: M017 Alumier MD Intensive Recovery HYDROCORTISONE Alumier Labs d9b79ea1-6558-543c-e053-2995a90ae53e 2025-08-06 Warnings Exact identifier application number: M017
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