Home NDC 10237-798-35 Orajel Cold Sore Touch Free - Single Dose
Product NDC 10237-798
Requested package NDC 10237-798-35
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10237-798 10237-798-35 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10237-798 10237-798-35 I Inactivated by FDA excluded / ndc_excluded.zip 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 131 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eagle Brand Medicated Roll On MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 1bc2f688-d0c4-690e-e063-6294a90abc38 2024-06-25 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 1b9fdac0-9fb0-e669-e063-6394a90aece9 2024-06-24 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN Asclemed USA, Inc. 97d506bd-3215-4e2e-9914-af1c174dd4ab 2024-06-20 Warnings Exact identifier application number: M017 ABREVA Rapid Pain Relief GLYCERIN, LIDOCAINE Haleon US Holdings LLC 65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d 2024-06-20 Warnings Exact identifier application number: M017 Frankie Avalons ZERO PAIN Roll-On Pain Reliever CAPSAICIN WHY ENTERPRISES LLC e32acb5f-5bc3-4228-b037-6315d080f556 2024-06-17 Warnings Exact identifier application number: M017 PUREGEN LABS Pain Relief 4 Lidocaine LIDOCAINE Advanced Rx LLC 9dff40d8-8d7e-4629-bea5-987f5e68477d 2024-06-11 Warnings Exact identifier application number: M017 SMOOTH GATOR Head-Ezz Analgesic MENTHOL Smooth Gator LLC 02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd 2024-06-10 Warnings Exact identifier application number: M017 FIRST AID BURN LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE Epic Medical Supply Corp bd1b1873-e900-45eb-96a0-28f782b5a7cd 2024-06-04 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE Chain Drug Marketing Association Inc. 1c834ba0-86b6-8e61-e063-6394a90a192d 2024-06-04 Warnings Exact identifier application number: M017 HealthWise Feminine Anti-itch Cream BENZOCAINE, RESORCINOL Veridian Healthcare 19fe7c3b-58e2-6c16-e063-6394a90a612a 2024-06-03 Warnings Exact identifier application number: M017 THE SOLUTION NUMBING LIDOCAINE HYDROCHLORIDE SCALP TECH INC 184be4cc-b0b9-7882-e063-6394a90a8e7e 2024-05-25 Warnings Exact identifier application number: M017 Methyl Salicylate 25 Percent METHYL SALICYLATE Alexso, Inc d8b8b0ba-69e9-4965-bf9b-6db21db69b34 2024-05-23 Warnings Exact identifier application number: M017 Meijer Medicated Chest Rub CAMPHOR, MENTHOL, EUCALYPTUS OIL Meijer Distribution 07ecc6a7-bbe3-35cf-e063-6394a90a2180 2024-05-22 Warnings Exact identifier application number: M017 TheraCare Hydrocortisone Cream HYDROCORTISONE Veridian Healthcare 01cb7b47-2c3c-707d-e063-6294a90a5d97 2024-05-21 Warnings Exact identifier application number: M017 TheraCare 4% Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare c808aa05-9d49-cc9f-e053-2a95a90a50f3 2024-05-21 Warnings Exact identifier application number: M017 TheraCare 4% Lidocaine and 1% Menthol Cream MENTHOL AND LIDOCAINE Veridian Healthcare c80ba251-91a5-0858-e053-2995a90a9cff 2024-05-21 Warnings Exact identifier application number: M017 HealthWise Menthol Roll-On MENTHOL Veridian Healthcare 102d57a5-6449-f825-e063-6294a90a8844 2024-05-21 Warnings Exact identifier application number: M017 SAFLY Burn LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 3aca2568-d10f-4b14-861b-6c741c106829 2024-05-17 Warnings Exact identifier application number: M017 HealthWise Menthol 4% Roll-On MENTHOL Veridian Healthcare 1894ef00-ba05-0e02-e063-6394a90ab982 2024-05-16 Warnings Exact identifier application number: M017 Leader Poison Ivy Wash PRAMOXINE HYDROCHLORIDE LOTION Cardinal Health, 110 dba Leader 81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c 2024-05-13 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