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 89 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Patch LIDOCAINE Shenzhen Finona Information Technology Co., Ltd 3875bde5-2e1a-5fdf-e063-6294a90a3c0d 2025-06-26 Warnings Exact identifier application number: M017 SupreH Bee Venom Arthritis Pain Relieving Cream SUPREH BEE VENOM ARTHRITIS PAIN RELIEVING CREAM Shenzhen Xinxin Yunhai Technology Co., Ltd. 3876cc44-7f3a-b084-e063-6294a90a6142 2025-06-26 Warnings Exact identifier application number: M017 MediBalm HYDROCORTISONE BalmRx, LLC 324dd151-84c5-3e2f-e063-6394a90a569d 2025-06-26 Warnings Exact identifier application number: M017 PHIZICO Pain Relief MENTHOL ER3 BRANDS INC. 72715dc5-d1e7-4b4b-8e28-4e367abba322 2025-06-25 Warnings Exact identifier application number: M017 Diva Cramp Care Cream METHYL SALICYLATE, MENTHOL, CAMPHOR Avaria Health & Beauty Corp 37368566-b14e-4d5c-bdde-6eea9073974f 2025-06-25 Warnings Exact identifier application number: M017 H2Ocean NOTHING TATTOO GLIDE AFTERCARE MAX STRENGTH LIDOCAINE HCL H2Ocean, LLC 386bf11b-1d71-44bf-e063-6394a90a2817 2025-06-25 Warnings Exact identifier application number: M017 Burn Relief Extra Strength Kool-Down LIDOCAINE - 3.9% Kool-Down Inc 827fec2f-db3c-adbb-e053-2a91aa0a7c17 2025-06-25 Warnings Exact identifier application number: M017 Hilook Blue Gel Anesthetic LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 1b9db681-a297-5aa9-e063-6394a90a80ea 2025-06-25 Warnings Exact identifier application number: M017 Hilook Numbing Cream LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 1b9f1a4c-ca0b-d820-e063-6394a90a3239 2025-06-25 Warnings Exact identifier application number: M017 Lidocaine Knee Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 384c1ff8-80bd-86cb-e063-6394a90a2d65 2025-06-24 Warnings Exact identifier application number: M017 Aroamas Cot Nicotine Transdermal Patches Kit NICOTINE TRANSDERMAL PATCHES PCHEERY LLC 38576022-9413-c9af-e063-6294a90afd46 2025-06-24 Warnings Exact identifier application number: M017 NERVE REVERSE PAIN RELIEF MENTHOL Pogue Medical Services da97bcc6-5aa8-48e2-a2c2-c937745bf6d3 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief Menthol Roll-On MENTHOL Respect Manufacturing Corporation 05a6067a-287a-52d4-e063-6394a90a2c4e 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief 500mg Hemp Menthol Cream MENTHOL Respect Manufacturing Corporation 06c4640a-ee42-5d1a-e063-6394a90ad254 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief 1000mg Hemp Menthol Cream MENTHOL Respect Manufacturing Corporation 06e944e8-71f6-9fe9-e063-6294a90a8c37 2025-06-23 Warnings Exact identifier application number: M017 Procure gel MENTHOL TWIN MED, LLC e69c0b68-d408-9fd2-e053-2a95a90ac934 2025-06-20 Warnings Exact identifier application number: M017 A Health Itch Relief Gel ITCH RELIEF GEL Bionpharma, Inc. 38040732-48c9-3533-e063-6394a90af10a 2025-06-20 Warnings Exact identifier application number: M017 SCHOELIF Numbing Cream NUMBING CREAM Guangzhou Qiexiran Cosmetics Co., Ltd. 37eaabb7-884e-0bd5-e063-6294a90ae063 2025-06-19 Warnings Exact identifier application number: M017 Re-Lieved Lidocaine Patch LIDOCAINE PATCH 4% Transfer Technology 37ee539c-df7e-511d-e063-6394a90a4469 2025-06-19 Warnings Exact identifier application number: M017 Re-Lieved Lidocaine Patch LIDOCAINE PATCH 4% Transfer Technology 37eef80a-556f-b090-e063-6294a90a151b 2025-06-19 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