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 96 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NOVUM APR MENTHOL NOVUM SOLUTIONS INC 1b869a1f-5787-4d03-a546-43a8217b2b2c 2025-04-07 Warnings Exact identifier application number: M017 MAG 5 PT ROLL-ON PAIN RELIEF COOLING MENTHOL RENU LABORATORIES, LLC 31e4fa2c-3a98-d618-e063-6394a90aec1c 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC cc7cbf4a-8274-e463-e053-2995a90a51e0 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC bdee018a-2c3c-3116-e053-2a95a90ac8d8 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC bdee2b65-2759-0e62-e053-2a95a90a0378 2025-04-07 Warnings Exact identifier application number: M017 RockSauce ICY COLD PAIN RELIEF MENTHOL Implus Footcare, LLC bdc7c7f3-ac98-8fe9-e053-2a95a90a2663 2025-04-07 Warnings Exact identifier application number: M017 RockSauce ICY COLD PAIN RELIEF MENTHOL Implus Footcare, LLC bd4fdff1-9174-31c2-e053-2a95a90a749f 2025-04-07 Warnings Exact identifier application number: M017 GREEN GUARD Topical Pain Relief LIDOCAINE HCI Ultra Distributors Inc b6f0041c-47fc-0bcd-e053-2a95a90ab1f9 2025-04-07 Warnings Exact identifier application number: M017 CBD Clinic Pain Relief - Level 5 MENTHOL, CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0ebc1c6-93fb-efd6-e053-2995a90a25bb 2025-04-07 Warnings Exact identifier application number: M017 CBD Clinic Pain Relief - Level 4 MENTHOL, CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0e9ac7c-a840-2e05-e053-2a95a90a33f1 2025-04-07 Warnings Exact identifier application number: M017 CBDMEDIC Active Sport Pain Relief CAMPHOR AND MENTHOL ABACUS HEALTH PRODUCTS, INC. f0ec5f47-2f8e-0558-e053-2a95a90aa7ca 2025-04-07 Warnings Exact identifier application number: M017 Hot Cold Medicated Patches HOT COLD MEDICATED PATCHES Henan Enokon Medical Instrument Co., Ltd. 159266a8-94fa-e2ff-e063-6394a90a9a77 2025-04-02 Warnings Exact identifier application number: M017 Pain Relief Patch PAIN RELIEF PATCH Henan Enokon Medical Instrument Co., Ltd. 1592d29d-e275-a44d-e063-6294a90ab17d 2025-04-02 Warnings Exact identifier application number: M017 Jointflex CAMPHOR Strides Consumer LLC 766b73f2-67bd-4d5c-805c-1057b3981ebf 2025-04-02 Warnings Exact identifier application number: M017 Olu Pain Management LIDOCAINE AND CAMPHOR Asclemed USA, Inc. d4d556c1-b64b-4b8e-8e4b-4f40eda24250 2025-04-01 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate TROLAMINE SALICYLATE TELEBRANDS CORP 31ce185e-07b7-d837-e063-6394a90a1fb0 2025-04-01 Warnings Exact identifier application number: M017 CVS Pain Relief MENTHOL 10.5% CVS d0ea80ce-38b2-acde-e053-2995a90a47e5 2025-03-31 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE A2A Integrated Pharmaceuticals, LLC 31431866-6fb5-2acd-e063-6294a90ac520 2025-03-31 Warnings Exact identifier application number: M017 Citrus Cleansing Foot Soak and Body Soak CAMPHOR SANSAR, LLC f136616d-9f32-4e55-a495-b7466fd68526 2025-03-28 Warnings Exact identifier application number: M017 Zpol ULTRA MENTHOL, METHYL SALICYLATE Laboratorios Zepol S.A. 1a1433a6-8d04-96df-e063-6394a90a987b 2025-03-27 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