Home NDC 10237-798 Orajel Cold Sore Touch Free - Single Dose
Product NDC 10237-798
11-digit product format 102370798
Labeler code 10237
Product ID 10237-798_51b6fb8e-eeba-a04a-e063-6294a90a610f
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride, Benzocaine
Dosage form LIQUID
Route TOPICAL
Labeler Church & Dwight Co., Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-01
Substance BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength 1.3; 50 mg/mL; mg/mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10237-798-35 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10237-798-35 367a005e9d99…383a685ebd0f…
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 Cold Sore Touch Free - Single Dose
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL BENZOCAINE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2572114 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10237-798-35 Orajel Cold Sore Touch Free - Single Dose 3.5 mL in 1 VIAL, SINGLE-DOSE LIQUID 3.5 6 10237-798-35 Orajel Cold Sore Touch Free - Single Dose 6 in 1 PACKAGE LIQUID 6 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-798 ORAJEL COLD SORE TOUCH FREE - SINGLE DOSE (BENZALKONIUM CHLORIDE, BENZOCAINE) LIQUID [CHURCH & DWIGHT CO., INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250330_ce40829e-941f-2548-e053-2995a90a1e0e.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 39 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LIGHTS Insect Sting Relief Pad BENZOCAINE Lights Medical Manufacture Co., Ltd. ccb4185c-1a67-4775-9392-16bc0f7df3cc 2026-01-21 Warnings Exact identifier application number: M017 Equate Pain Relieving Cream Lidocaine LIDOCAINE Wal-Mart Stores Inc 52b91508-22aa-4c4b-94f4-977f14a01dad 2026-01-20 Warnings Exact identifier application number: M017 Easment advanced absorption cream CAPSAICIN 0.1% Easment LLC 48de3ced-f67f-7c86-e063-6294a90a340c 2026-01-20 Warnings Exact identifier application number: M017 Black Cobra Tattoo NumbingSpray 4% Lidocaine LIDOCAINE Foshan Sugar Max Cosmetics CO.,Ltd 3605fcbf-63c8-87b5-e063-6294a90a9c3e 2026-01-19 Warnings Exact identifier application number: M017 Black Cobra Tattoo Numbing Cream 4% Lidocaine LIDOCAINE Foshan Sugar Max Cosmetics CO.,Ltd 3605961a-d596-9c4a-e063-6394a90a99dc 2026-01-19 Warnings Exact identifier application number: M017 Bakers Best Arthritis Pain Relief HISTAMINE DIHYDROCHLORIDE Baker's Best Health Products, LLC 869735f9-335e-4a5e-adfc-91167ae943c5 2026-01-19 Warnings Exact identifier application number: M017 SIMPLY VITAL PAIN RELIEF HEMP MENTHOL ALPHA PLANTS INC c14f4c06-cfe5-497e-9f9e-b2ba442e61bb 2026-01-19 Warnings Exact identifier application number: M017 AsperFlex MENTHOL AND METHYL SALICYLATE Akron Pharma Inc. 117de175-976d-44f3-85ed-3d127fbe3a7c 2026-01-19 Warnings Exact identifier application number: M017 Equate Pain Relieving Ultra Strength CAMPHOR, MENTHOL, METHYL SALICYLATE Wal-Mart Stores Inc 5ed1d7b3-925e-4a18-8e15-636f5b442ad7 2026-01-19 Warnings Exact identifier application number: M017 Equate Medicated Pain Relieving Patch, Large 6-Count CAMPHOR, MENTHOL, METHYL SALICYLATE Walmart Stores Inc 2c25cd7a-7e7b-5add-e063-6294a90a9e9b 2026-01-19 Warnings Exact identifier application number: M017 Equate Hydrocortione 1% HYDROCORTISONE Walmart Inc. 85b7f620-cc95-4333-b124-bbcc8fd5f7eb 2026-01-19 Warnings Exact identifier application number: M017 GuruNanda Pain Relief MENTHOL GURUNANDA, LLC 3f1d146e-0d18-7f2f-e063-6394a90ab816 2026-01-19 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine LIDOCAINE Chattem, Inc. 7ad8efa9-7031-4cd0-be1d-6dee63091fd1 2026-01-19 Warnings Exact identifier application number: M017 Best Choice Targeted Warming Capsaicin Heat Patch CAPSAICIN Valu Merchandisers Company 24ca40b7-e17b-42a3-bcc8-6861b9a5934a 2026-01-18 Warnings Exact identifier application number: M017 TOPCARE PAIN RELIEF PATCHES LIDOCAINE TOPCO ASSOCIATES, LLC fa2f7768-e779-4409-aad3-6c33ce2e6b36 2026-01-18 Warnings Exact identifier application number: M017 Neuropathy Pain Relief Cream MENTHOL CREAM Owell Naturals Brand, LLC 48979093-2992-5fd8-e063-6394a90a815d 2026-01-17 Warnings Exact identifier application number: M017 CVS Lidocaine Pain Relief Cream LIDOCAINE HYDROCHLORIDE CVS Pharmacy 45c4f946-13b9-7a0a-e063-6394a90a7353 2026-01-16 Warnings Exact identifier application number: M017 TopCare Pain Relieving Cream LIDOCAINE HCL 4% Topco Associates, LLC 4885a7e6-a127-450a-e063-6294a90a4f91 2026-01-16 Warnings Exact identifier application number: M017 Calmara CALMARA Dynarex Corporation 487393e9-6619-6033-e063-6294a90a68b2 2026-01-16 Warnings Exact identifier application number: M017 Maximum Strength Hydrocortisone HYDROCORTISONE OINTMENT Walgreens 7088092c-3a5f-4fcc-84cc-931d238f7501 2026-01-15 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 10237-798-35 10237079835 6 VIAL, SINGLE-DOSE in 1 PACKAGE (10237-798-35) / 3.5 mL in 1 VIAL, SINGLE-DOSE 2021-09-01 0000-00-00 No No Current