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 50 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PAIN RELIEF PATCHES LIDOCAINE Ahold U.S.A., Inc, 7e7a813e-424d-4a78-9c72-541c3c62606a 2025-12-28 Warnings Exact identifier application number: M017 Amazon Basics Cold and Hot Medicated Patch MENTHOL Amazon.com Services LLC e3b4db12-c846-b984-e053-2a95a90a8e9a 2025-12-28 Warnings Exact identifier application number: M017 Amazon Basics Pain Relief Patch with 4% Lidocaine LIDOCAINE Amazon.com Services LLC e3b4f9b1-ac6b-cb2a-e053-2a95a90a9e1e 2025-12-28 Warnings Exact identifier application number: M017 Absorbine Jr Neck and Shoulder ABSORBINE JR NECK AND SHOULDER Clarion Brands LLC 22f2f191-9146-3075-e063-6394a90aef5f 2025-12-28 Warnings Exact identifier application number: M017 Absorbine Jr. Pain Relieving Knee Patch ABSORBINE JR. PAIN RELIEVING KNEE PATCH Clarion Brands, LLC 22f71254-e521-2d82-e063-6394a90a12d8 2025-12-28 Warnings Exact identifier application number: M017 Absorbine Jr Back Patch ABSORBINE JR BACK PATCH Clarion Brands LLC. 22f5147e-ff2b-4ae8-e063-6394a90a4e54 2025-12-28 Warnings Exact identifier application number: M017 Absorbine Jr. Pro Rollon ABSORBINE JR. PRO ROLLON Clarion Brands, LLC 470efcd0-d350-3dc4-e063-6394a90ab8c1 2025-12-28 Warnings Exact identifier application number: M017 Med Rub Balm ACHES AND PAIN BALM Wellmetech Pharmaceutical Industries SDN BHD a5801566-6bbe-44f6-8761-9c1ce3096900 2025-12-27 Warnings Exact identifier application number: M017 N-Labs ArcticZen Pain Relief Knee CAMPHOR (SYNTHETIC), MENTHOL Nutriomo Labs PTE., LTD 46e92db7-a48b-2c7a-e063-6394a90a438e 2025-12-27 Warnings Exact identifier application number: M017 Absorbine Jr. Plus MENTHOL Clarion Brands, LLC 46f4ad3c-7418-a6bf-e063-6394a90a4eb8 2025-12-27 Warnings Exact identifier application number: M017 Equate Lidocaine Cool and Heat LIDOCAINE 4% PLUS MENTHOL 1% Walmart Stores Inc b86769c3-a0b4-c481-e053-2a95a90af38b 2025-12-27 Warnings Exact identifier application number: M017 Medicated Body Extra Strength Powder MENTHOL 0.80% Walmart Stores Inc b0786418-7b28-d316-e053-2995a90a3ab5 2025-12-27 Warnings Exact identifier application number: M017 Maximum Strength Medicated Foot Powder MEDICATED FOOT POWDER Walmart Stores Inc b0794d48-eb8b-55c9-e053-2995a90a5b38 2025-12-27 Warnings Exact identifier application number: M017 Walgreens 24-Hour Lidocaine Patch LIDOCAINE 4% Walgreens Company b8402924-b5fc-0acd-e053-2a95a90a1805 2025-12-27 Warnings Exact identifier application number: M017 Frankincense and Myrrh Foot Pain Relief MENTHOL WISE CONSUMER PRODUCTS CO. 115f1abc-34aa-3c20-e063-6294a90a9764 2025-12-26 Warnings Exact identifier application number: M017 Soothing Nerve Relief MENTHOL Wise Consumer Products 46e23c95-1a36-214e-e063-6394a90a98a8 2025-12-26 Warnings Exact identifier application number: M017 Frankincense and Myrrh Foot Pain Relief Combo Pack MENTHOL WISE CONSUMER PRODUCTS CO. 46e2c8b6-bd94-7100-e063-6294a90ac998 2025-12-26 Warnings Exact identifier application number: M017 Pain Patch Perfecto 24 Hours Lidocaine 4 % Patch LIDOCAINE Painpatchperfecto LLC a281c3e9-1c48-4905-98cc-3cedf6042adc 2025-12-25 Warnings Exact identifier application number: M017 Aloe UP SPF 33 Mineral ZINC OXIDE Aloe Care International, LLC 35aa6196-682d-8f32-e063-6394a90aad99 2025-12-24 Warnings Exact identifier application number: M017 ETADERM Numbing Cream LIDOCAINE NUEPHASE LLC 5292c6ff-b878-4e71-878b-4bf08207612e 2025-12-24 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