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 33 of 156 · 3,115 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tommie Copper Cooling Roller Lavender Scent MENTHOL 4% Tommie Copper, Inc. 4bbfd4d1-9036-bc20-e063-6394a90a3feb 2026-02-26 Warnings Exact identifier application number: M017 HQLSEY QUIT SMOKING PATCHES QUIT SMOKING PATCHES Hansen Pharmaceutical Investment Co., Limited 4ba317fb-714a-05cb-e063-6394a90a382f 2026-02-25 Warnings Exact identifier application number: M017 Advanced Pain Relief Cream With 5 % Natural Menthol MENTHOL Allure Labs 4bab9c43-86d4-dad2-e063-6394a90ac095 2026-02-25 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Patch MENTHOL, CAMPHOR, METHYL SALICYLATE Walgreen Co. 4223c74a-12fb-51a3-e063-6294a90a0deb 2026-02-25 Warnings Exact identifier application number: M017 Advanced Pain Relief Roll-On Gel With 5% Natural Menthol MENTHOL Allure Labs 4bad597f-acb2-a122-e063-6394a90a9fcf 2026-02-25 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy LIDOCAINE InterMed Laboratories Private Limited 4bade8a9-43bd-b649-e063-6294a90a81da 2026-02-25 Warnings Exact identifier application number: M017 dermaFIT Muscle Retention Cream Strength MENTHOL EX Healthcare Inc. 4620c41a-2187-00f5-e063-6394a90a613c 2026-02-23 Warnings Exact identifier application number: M017 dermaFIT Muscle Retention Cream Sculpt MENTHOL EX Healthcare Inc. 4620d4ca-42e4-eeae-e063-6394a90a5c84 2026-02-23 Warnings Exact identifier application number: M017 dermaFIT Muscle Retention Cream Extra Strength MENTHOL EX Healthcare Inc. 4620ca7a-afe6-d063-e063-6394a90ab5db 2026-02-23 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Sportpharm LLC 9578b39e-3df7-4d75-abd7-f1d5524545e5 2026-02-23 Warnings Exact identifier application number: M017 0.5% LIDOCAINE BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. cf723c7b-495d-4bae-942c-561cf28af2d3 2026-02-21 Warnings Exact identifier application number: M017 Swiftalyn Numbing Cream MENTHOL 1% GENUINE INNOVATION LTD 4b2ebff2-2f50-e54b-e063-6294a90aaccb 2026-02-19 Warnings Exact identifier application number: M017 Equate Cold Therapy Pain Relieving MENTHOL Walmart Inc 46a3c9e9-5cd3-4bc4-e063-6394a90a7178 2026-02-19 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL, ZINC ACETATE Meijer, Inc. e11390ec-99a3-4ff1-a3c8-ca909f4f67b5 2026-02-19 Warnings, Adverse reactions Exact identifier application number: M017 Aloe Vera Gel LIDOCAINE HCL, MENTHOL Meijer, Inc. d0cc06c1-c0d5-42f0-82cd-8b704cbe1f46 2026-02-19 Warnings, Adverse reactions Exact identifier application number: M017 MENTHOL, CAMPHOR MENTHOL, CAMPHOR CHEMCO CORPORATION 4b1a0e6f-aa68-421c-e063-6294a90a426e 2026-02-18 Warnings Exact identifier application number: M017 Veiurkiu External Analgesic Cream LIDOCAINE BLOOMWELL GARDENS LLC 40ec5e6f-13dc-de04-e063-6294a90af5d5 2026-02-18 Warnings Exact identifier application number: M017 External Analgesic Cream with Menthol 5% MENTHOL 5% BLOOMWELL GARDENS LLC 402faa27-5305-c73d-e063-6394a90a36f2 2026-02-18 Warnings Exact identifier application number: M017 PAINGEL MENTHOL, METHYL SALICYLATE NACOR BUSINESS GROUP LLC 4b1d55e2-cf83-ffbd-e063-6294a90ad52f 2026-02-18 Warnings Exact identifier application number: M017 Alocane Anti-Itch HYDROCORTISONE 1% Quest Products, LLC 45252043-d41a-3cdd-e063-6394a90aa9e5 2026-02-18 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