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 112 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join QC Cool and Heat Roll-On MENTHOL 16% Chain Drug Marketing Association Inc d35e9dfa-8a28-fdb3-e053-2995a90abc52 2024-12-15 Warnings Exact identifier application number: M017 Meijer Cold and Hot Pain Relieving MENTHOL 16% Meijer bec62df3-06c9-a115-e053-2995a90a4267 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief MENTHOL 16% Tommie Copper, Inc. b4dfa5fa-2d61-db1e-e053-2a95a90a7ac8 2024-12-15 Warnings Exact identifier application number: M017 Pain Relief Liquid Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. c9f0447e-de43-16a5-e053-2995a90a05c1 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Maximum Strength TROLAMINE SALICYLATE 10% Tommie Copper, Inc. b622c14f-9bf3-0bbd-e053-2a95a90a2adc 2024-12-15 Warnings Exact identifier application number: M017 Copperlife Pain Relief TROLAMINE SALICYLATE 10% Tommie Copper, Inc. c94d00f9-42ce-1d43-e053-2a95a90a058d 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. b6c3d6eb-b485-33b8-e053-2a95a90a41e1 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. b4cd4fed-e8c8-db85-e053-2995a90a708b 2024-12-15 Warnings Exact identifier application number: M017 Copperlife Pain Relief Liquid MENTHOL 16% Tommie Copper, Inc. c93a0139-953b-5523-e053-2a95a90a0b2d 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief TROLAMINE SALICYLATE 10% Tommie Copper, Inc. ca011b03-a263-1908-e053-2995a90ad970 2024-12-15 Warnings Exact identifier application number: M017 Warrior Chiggerex Relief BENZOCAINE 10% Derma Care Research Labs, LLC dcf2f52b-2295-58e5-e053-2995a90a7fd8 2024-12-15 Warnings Exact identifier application number: M017 Capsaicin Cream CAPSAICIN Trifecta Pharmaceuticals USA LLC def8d341-06a7-0e9b-e053-2995a90a0ad6 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Original CAMPHOR, MENTHOL The Mentholatum Company 19e4b812-67c6-49fd-833a-b432100363f5 2024-12-13 Warnings Exact identifier application number: M017 Cold and Hot Medicated MENTHOL The Mentholatum Company 85bf425d-59d7-4462-ba46-292145460099 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Lidocaine Ice LIDOCAINE HCL, MENTHOL The Mentholatum Company 4d74cbab-31cd-4579-9360-6852ee215b5e 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Deep Heating Rub Extra Strength MENTHOL, METHYL SALICYLATE The Mentholatum Company f5684158-0d83-4031-b493-5422ddc73e78 2024-12-13 Warnings Exact identifier application number: M017 Discount Drug Mart Anti-Itch CAMPHOR, MENTHOL Discount Drug Mart 87d379da-103a-c751-e053-2995a90a56de 2024-12-13 Warnings Exact identifier application number: M017 Audiologist Anti-itch HYDROCORTISONE OAKTREE PRODUCTS, INC. 853e078e-1e91-d55f-e053-2991aa0a6dcd 2024-12-13 Warnings Exact identifier application number: M017 CVS Anti itch HYDROCORTISONE CVS 884df604-711b-4a3d-e053-2995a90a3a04 2024-12-13 Warnings Exact identifier application number: M017 Dermoplast Pain Relieving BENZOCAINE AND LEVOMENTHOL Advantice Health, LLC 2347f0b8-d463-422d-8583-65624d9a1a91 2024-12-12 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