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 57 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LenzaPro Flex LIDOCAINE/MENTHOL SOLA Pharmaceuticals ba498f1d-460b-f4e6-e053-2995a90a5755 2025-12-08 Warnings Exact identifier application number: M017 LidaFlex LIDOCAINE SOLA Pharmaceuticals b9e49529-13b4-1b0b-e053-2995a90adc7a 2025-12-08 Warnings Exact identifier application number: M017 Rugby Menthol Hot Cold Patch MENTHOL RUGBY LABORATORIES c68d29c2-9b56-4994-e053-2a95a90ae60e 2025-12-08 Warnings Exact identifier application number: M017 Neuracin Topical Gel NEURACIN TOPICAL ANALGESIC GEL SOLA Pharmaceuticals c3166926-30c2-2128-e053-2a95a90a0bf2 2025-12-08 Warnings Exact identifier application number: M017 Triceptin LIDOCAINE / MENTHOL / METHYL SALICYLATE SOLA Pharmaceuticals ef1b98ab-d2db-038c-e053-2995a90a94b4 2025-12-08 Warnings Exact identifier application number: M017 SynoFlex Patch SYNOFLEX PATCH Sola Pharmaceuticals de2042c4-6c5e-7365-e053-2a95a90ada2a 2025-12-08 Warnings Exact identifier application number: M017 AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1 NICOTINE TRANSDERMAL PATCHES PCHEERY LLC 457c860b-091d-8350-e063-6294a90a2f98 2025-12-08 Warnings Exact identifier application number: M017 AY BENDITO HEMP MENTHOL, CAMPHOR AY BENDITO INTERNATIONAL, INC 457c9bd6-2e72-03e5-e063-6394a90a558c 2025-12-08 Warnings Exact identifier application number: M017 AY BENDITO HEMP ROLL-ON CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC 3e552afc-9305-8825-e063-6294a90a1afe 2025-12-08 Warnings Exact identifier application number: M017 AY BENDITO HEMP CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC 457d89aa-4a84-94a6-e063-6294a90a20c0 2025-12-08 Warnings Exact identifier application number: M017 Gold Bond Medicated Anti-Itch PRAMOXINE HYDROCHLORIDE, MENTHOL Gold Bond Co LLC 4a2bd277-47dd-4ae6-9b4b-e0ae9aad226b 2025-12-05 Warnings Exact identifier application number: M017 Orajel for Cold Sores Double Medicated, Cream BENZOCAINE AND WHITE PETROLATUM Church & Dwight Co., Inc. b8699a40-8464-ca02-e053-2995a90a4260 2025-12-05 Warnings Exact identifier application number: M017 ndc (package): 10237-797-12 ndc (product): 10237-797 ndc11 (package): 10237079712 Thompson Hydrocortisone 1% HYDROCORTISONE Thompson f8740314-7e1f-815e-e053-6294a90a6eae 2025-12-05 Warnings Exact identifier application number: M017 JUST CBD SOOTHING UNSCENTED LIDOCAINE HCL Just Brands LLC 453f44e2-9e5b-8695-e063-6394a90a4389 2025-12-05 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON COOLING MENTHOL Just Brands LLC 453fa1a7-368c-ae50-e063-6294a90a5507 2025-12-05 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON WARMING CAMPHOR Just Brands LLC 4540221f-cf9f-9b6a-e063-6294a90adec3 2025-12-05 Warnings Exact identifier application number: M017 Gold Bond Extra Strength MENTHOL Gold Bond Co LLC 3e84375f-95d3-420c-b222-02a757412592 2025-12-04 Warnings Exact identifier application number: M017 Alocane Plus LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE Quest Products LLC b3ec09b9-7511-0895-e053-2a95a90a7840 2025-12-04 Warnings Exact identifier application number: M017 Gold Bond Medicated Pain and Itch Relief LIDOCAINE HYDROCHLORIDE Gold Bond Co LLC d240e9b8-3506-42ab-8a50-05e8d3fac4ff 2025-12-04 Warnings Exact identifier application number: M017 BLT Skin Cream BENZOCAINE, LIDOCAINE, TETRACAINE M2B Pharma LLC 9dc5db9d-9e0a-cd28-e053-2995a90a6bf7 2025-12-04 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