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 99 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Anti Itch ANTI ITCH Neilmed Pharmaceuticals Inc. 2fa74baf-e3d2-e099-e063-6394a90a1bae 2025-03-06 Warnings Exact identifier application number: M017 Thunder Fck Male Genital Desensitizer BENZOCAINE PRODUCT MAX GROUP INC 93188a42-0d3c-4159-bdc7-bbc5ec5c6744 2025-03-06 Warnings Exact identifier application number: M017 Body Action Climax Guard Delay BENZOCAINE PRODUCT MAX GROUP INC f88e0b42-974e-4f46-a93b-34b06320770a 2025-03-06 Warnings Exact identifier application number: M017 XENCARE INFLAMAX NATURAL TOPICAL PAIN MENTHOL, CAPSAICIN Xenex Laboratories Inc. 25b9621b-3c16-3cb9-e063-6294a90ab598 2025-03-06 Warnings Exact identifier application number: M017 Pain Relieving Cream CAMPHOR AND MENTHOL PAIN WIZARD LIMITED LIABILITY COMPANY 1cd37b69-2cfb-130d-e063-6394a90af50b 2025-03-06 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Walgreens Co. c22bba5c-bb6f-494e-987a-f6e36c1b4893 2025-03-06 Warnings Exact identifier application number: M017 Redicare Burn Gel REDICARE BURN GEL Redicare LLC 947ac362-acfb-3508-e053-2a95a90a2873 2025-03-05 Warnings Exact identifier application number: M017 Thera Plus Hydrocortisone Maximum Strength HYDROCORTISONE FOURSTAR GROUP USA, INC. c2bc8f0c-38ea-4124-bc51-bf22e6751a92 2025-03-04 Warnings Exact identifier application number: M017 Thera Plus Eczema Hydrocortisone Anti Itch HYDROCORTISONE Fourstar Group USA, Inc. 7c72217b-db9a-4573-9f14-4c11528fa452 2025-03-04 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc. fb89dca6-c0c0-4092-b3f5-e59c956c3d6c 2025-03-04 Warnings Exact identifier application number: M017 Peppermint soothing cream CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOL Henan Lijitang Medical Technology Co., Ltd. 2f6bc332-3006-710d-e063-6394a90acea5 2025-03-03 Warnings Exact identifier application number: M017 Thera Plus Pain Relief Arthritis and Muscle CAPSAICIN FOURSTAR GROUP USA, INC. dcff0a2d-7190-4b0c-abde-ba009b8ef005 2025-02-28 Warnings Exact identifier application number: M017 GoodSense Anti-Itch DIPHENHYDRAMINE HCL, ZINC ACETATE Geiss, Destin & Dunn, Inc 2f38bdfc-6135-1b8a-e063-6294a90a6703 2025-02-28 Warnings Exact identifier application number: M017 Capsaicin 0.05% Cream CAPSAICIN 0.05% Puretek Corporation 2cf17a28-711f-77bd-e063-6394a90a7061 2025-02-28 Warnings Exact identifier application number: M017 Lidocaine Pain-Relief Patches LIDOCAINE PATCH Meijer, Inc 2f247929-6bff-1e59-e063-6394a90acdba 2025-02-27 Warnings Exact identifier application number: M017 Lightning Products BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 555ac696-e761-4a5a-bed8-945dc64d5be5 2025-02-27 Warnings Exact identifier application number: M017 Hydrocortisone with aloe HYDROCORTISONE Encube Ethicals, Inc. 12a1774d-a97e-4787-b6b1-8e8cd40b7b70 2025-02-26 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Feminine Anti-Itch BENZOCAINE, RESORCINOL FOURSTAR GROUP USA, INC. 0007e3ea-882b-4000-8e70-2bcec2c08613 2025-02-26 Warnings Exact identifier application number: M017 Tattoo numbing cream LIDOCAINE BLOOMWELL GARDENS LLC 2ea9d34e-408d-f8d6-e063-6394a90a72a4 2025-02-26 Warnings Exact identifier application number: M017 Icy Hot Pro No-Mess CAMPHOR, MENTHOL Chattem, Inc. 9e8fedf5-fb59-4531-b288-715f851ee05b 2025-02-26 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