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 146 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SUPER BLUE STUFF Pain Relief Cream MENTHOL BLUE SPRING WELLNESS, L.L.C. 066a2106-2e25-4df6-9a8d-4417ba190205 2023-11-10 Warnings Exact identifier application number: M017 INVIGO FLEX Pain Relief Gel MENTHOL WYNNPHARM INC. 909e1d8c-c517-4d6a-8682-894f042c00f8 2023-11-10 Warnings Exact identifier application number: M017 ARNIMAX Penetrating Pain Relief Gel MENTHOL WYNNPHARM INC. 3a31f805-19c6-4036-a663-ebef9b212007 2023-11-10 Warnings Exact identifier application number: M017 KERA HC HYDROCORTISONE Clinical Therapeutic Solutions ac215c8f-b224-480c-9295-3a34316293ba 2023-11-10 Warnings Exact identifier application number: M017 ALO THERAPEUTIC MASSAGE PAIN RELIEVING MENTHOL, HISTAMINE DIHYDROCHLORIDE Theraplex Solutions da004500-5e48-487b-b96f-520a3094096c 2023-11-10 Warnings Exact identifier application number: M017 Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING MENTHOL, METHYL SALICYLATE Rexall Sundown, LLC 55c55f1c-d2b3-6363-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 NEUROFLEX Topical Pain Relieving Liquid CAMPHOR (SYNTHETIC), MENTHOL Almark Products Inc 6da3aa84-7a01-4041-8792-a4bbf49e6e4e 2023-11-10 Warnings Exact identifier application number: M017 SMOOTH GATOR 60-second Pain Relief CAMPHOR (SYNTHETIC), MENTHOL Smooth Gator LLC 3b74b542-202f-469e-8025-4372e95e6b01 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f8b8d1-a20b-54b0-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f92e71-fe2e-16f4-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M017 Teeter Renew Muscles Pain Relieving METHYL SALICYLATE, MENTHOL STL International INC b90dc5b9-c31d-4770-a291-98d036ae8723 2023-11-10 Warnings Exact identifier application number: M017 SMOOTH GATOR Foot and Leg Rub CAMPHOR (SYNTHETIC), MENTHOL Smooth Gator LLC 57094238-506b-48c1-8eb9-fe904be80df0 2023-11-10 Warnings Exact identifier application number: M017 SKIN A COOL Hydrocortisone Anti-Itch HYDROCORTISONE Ana-Cool, LLC e3ea7406-e494-4038-9b28-8d0a28b4b834 2023-11-10 Warnings Exact identifier application number: M017 Teeter reNEW MUSCLES Pain Relieving METHYL SALICYLATE, MENTHOL STL International INC ebc777b0-d141-4a62-9366-d14787eaefe0 2023-11-10 Warnings Exact identifier application number: M017 FEELGOOD LAB Natural Pain Cream MENTHOL The Feel Good Lab, LLC 799d464c-aaf1-429a-877b-2a692397bb49 2023-11-10 Warnings Exact identifier application number: M017 HIGHER CONTROL Male Climax Control Lubricating BENZOCAINE Product Max Group Inc 5f5fd127-34c5-403a-aa95-c9874ae79492 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f93076-1f68-58e6-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f9622e-27c7-6a5d-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 FEEL GOOD LAB Natural Pain Cream MENTHOL THE FEEL GOOD LAB, LLC 774a72b1-b719-4217-846e-7f9921fd1b16 2023-11-10 Warnings Exact identifier application number: M017 BODY ACTION PRODUCTS Climax Control Gel BENZOCAINE PRODUCT MAX GROUP INC 53e746cc-0078-4381-bf0b-9c8f98d66904 2023-11-10 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