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 37 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 WALMART STORES INC b82cfe42-f521-4784-8c60-98481524c5ec 2026-01-29 Warnings Exact identifier application number: M017 Equate Pain Relief Patch Camphor/Menthol/Salicylate CAMPHOR, MENTHOL, METHYL SALICYLATE Walmart Stores Inc b869848c-21e2-5ca2-e053-2995a90a86f2 2026-01-29 Warnings Exact identifier application number: M017 HEATING PAIN RELIEF METHYL SALICYLATE, MENTHOL SUNSET NOVELTIES, INC 498cd2aa-ee59-67b5-e063-6294a90ac242 2026-01-29 Warnings Exact identifier application number: M017 COOLING PAIN RELIEF MENTHOL, CAMPHOR SUNSET NOVELTIES, INC 498d76d8-788b-4cc7-e063-6294a90a1696 2026-01-29 Warnings Exact identifier application number: M017 MQUPIN Lidocaine Gel-Patch LIDOCAINE GEL-PATCH Zhengzhou Miaoqi Medical Technology Co., Ltd. 49703717-69a6-e480-e063-6394a90ac69c 2026-01-28 Warnings Exact identifier application number: M017 MQXUNMI LIDOCAINE Pain Relief Patch LIDOCAINE PAIN RELIEF PATCH Zhengzhou Miaoqi Medical Technology Co., Ltd. 49706db7-bacd-190f-e063-6394a90a3a8e 2026-01-28 Warnings Exact identifier application number: M017 Joint and Muscle Relief Topical Analgesic MENTHOL Smart Cookie Solutions 1ecf56b1-ffcb-486f-9fdd-d4dc92aefc1d 2026-01-28 Warnings Exact identifier application number: M017 VonaFlex Effective Pain Relief Topical Analgesic LIDOCAINE HYDROCHLORIDE OPTIMAL LABORATORIES, LLC 0901244a-7d41-413a-b424-92a807532f28 2026-01-28 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel Patch LIDOCAINE PAIN RELIEF Dynarex 960e4240-cd09-2560-e053-2a95a90a7bcf 2026-01-28 Warnings Exact identifier application number: M017 ALOE ICE SUNBURN RELIEF LIDOCAINE HYDROCHLORIDE Aloe Care International, LLC 56866fa8-052e-497c-a954-978d7d628949 2026-01-28 Warnings Exact identifier application number: M017 Walgreens Original Strength Anti Itch DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Walgreen Company a6a49dbb-74c7-47ca-88f2-3bb3d9acf914 2026-01-28 Warnings Exact identifier application number: M017 Flobow QUIT SMOKING Nicotine NICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINE Jiangxi Yudexi Pharmaceutical Co., LTD 495b10ce-3d2d-1aa4-e063-6294a90a4f35 2026-01-27 Warnings Exact identifier application number: M017 PAIN REUSEABLE PAIN Shenzhen Mengyue Technology Co., Ltd. 44e058fc-e1c0-742b-e063-6294a90ad225 2026-01-27 Warnings Exact identifier application number: M017 HealthWise Pain Relieving Cream Lavender MENTHOL Veridian Healthcare 495eb6e9-69da-f7b6-e063-6294a90accee 2026-01-27 Warnings Exact identifier application number: M017 HealthWise Pain Relieving Cream MENTHOL Veridian Healthcare 49548ab2-267e-1e2a-e063-6394a90ab391 2026-01-27 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL Wal-Mart Stores, Inc. 03feaaef-7401-d464-e063-6294a90a2b2d 2026-01-27 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE STRATEGIC SOURCING SERVICES LLC 4a113699-1eb7-49b8-8cdf-2ad57db89b81 2026-01-27 Warnings Exact identifier application number: M017 Healthy Back Institute Rub On Relief ANALGESIC Fullstack Fulfillment 284c29a3-5722-ce70-e063-6394a90a7fa0 2026-01-26 Warnings Exact identifier application number: M017 Velocx for Joint and Muscle Pain Roll-On Applicator MENTHOL, METHYL SALICYLATE JMAD Consulting LLC, dba JMAD Labs dbf3eaa3-d85e-46b1-b4a5-a87ba4dc5d21 2026-01-26 Warnings Exact identifier application number: M017 CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS CAPSAICIN Meijer Distribution Inc 9b91658f-c15f-4222-bbd9-881b29de3b6e 2026-01-26 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