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 21 of 156 · 3,115 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BonicaEaseX Pain Relieving Lidocaine LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 7486fe89-a377-4a37-997d-e3bd16b891a7 2026-05-11 Warnings Exact identifier application number: M017 YYSDMVY NUMBING Cream LIDOCAINE 4% NUMBING CREAM Jiangxi Yudexi Pharmaceutical Co., LTD 5195f5ec-8524-77f5-e063-6294a90abdc2 2026-05-11 Warnings Exact identifier application number: M017 Lightning X Burn Relief Gel LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 515eb4cc-63af-c11d-e063-6294a90a13ca 2026-05-09 Warnings Exact identifier application number: M017 Albertson Lidocaine, Menthol Pain Relief Medicated Patch LIDOCAINE AND MENTHOL Safeway dc647647-90ec-6beb-e053-2a95a90a7982 2026-05-09 Warnings Exact identifier application number: M017 5 Elementum Lidocaine Male Genital Desensitizer LIDOCAINE MALE GENITAL DESENSITIZER MSVENTURESGROUP O 514b1738-886e-a95d-e063-6294a90aa707 2026-05-08 Warnings Exact identifier application number: M017 Kroger Muscle Rub Cream MENTHOL, CAMPHOR, METHYL SALICYLATE Kroger Co. 45c8c79a-b4b4-d4be-e063-6394a90a9251 2026-05-08 Warnings Exact identifier application number: M017 Walmart Equate Aloe Sunburn Relief Cooling LIDOCAINE WAL-MART STORES INC. 51540f6b-596f-bc47-e063-6294a90a46ae 2026-05-08 Warnings Exact identifier application number: M017 Capsaicin 0.035% cream CAPSAICIN Medcore LLC 0236e1e4-c26c-4fff-a83b-143ce26d93bf 2026-05-07 Warnings Exact identifier application number: M017 Lidocaine 4% Cream LIDOCAINE Medcore LLC 111cb421-ba3b-4772-ab60-d31eb4183168 2026-05-07 Warnings Exact identifier application number: M017 Lidocaine 5% Cream LIDOCAINE Medcore LLC 15d02b42-bf8b-486a-a081-f6d17cc11ec7 2026-05-07 Warnings Exact identifier application number: M017 JenGufun LIDOCAINE Pain Relief Gel-Patch LIDOCAINE PAIN RELIEF GEL-PATCH Henan Kangdi Medical Devices Co., Ltd. 51363a41-5dcc-6a3b-e063-6294a90a6c27 2026-05-07 Warnings Exact identifier application number: M017 Lidoxi LIDOCAINE T&T Pharma Holdings LLC 513c517e-c098-02aa-e063-6294a90ac8a4 2026-05-07 Warnings Exact identifier application number: M017 Harris Teeter Hydrocortisone HYDROCORTISONE HARRIS TEETER LLC 4e8199f8-96ec-5342-e063-6294a90afb2d 2026-05-07 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc. 5114cdba-96a1-c399-e063-6294a90aac12 2026-05-06 Warnings Exact identifier application number: M017 New Terocin METHYL SALICYLATE, CAPSAICIN, AND MENTHOL ASCLEMED USA INC. 68dc0231-3364-448b-bde9-f19fa122c765 2026-05-05 Warnings Exact identifier application number: M017 Lidocaine 4% Patch LIDOCAINE 4% SOLA Pharmaceuticals c31957dd-edea-ce98-e053-2a95a90a9c2d 2026-05-05 Warnings Exact identifier application number: M017 Biofreeze Triple Target Gel CAMPHOR, CAPSAICIN, MENTHOL Reckitt Benckiser LLC 511852c8-7428-3234-e063-6394a90a5bc2 2026-05-05 Warnings Exact identifier application number: M017 5Kind DMSO Pain Relieving CAMPHOR (SYNTHETIC) 5Kind Trading LTD 62b55114-47f4-473a-8406-78238c3c1fa2 2026-05-04 Warnings Exact identifier application number: M017 Zinc Oxide with Menthol and White Petrolatum MENTHOL, ZINC OXIDE, WHITE PETROLATUM Aldermed Inc. f993fc0a-bd80-4345-a948-65ac03f910e2 2026-05-04 Warnings Exact identifier application number: M017 EVERLIT CARE PRODUCTS BURN RELIEF LIDOCAINE HYDROCHLORIDE EVERLIT GLOBAL INC. d7ec5720-4d1f-4943-ae36-c7d6acbae7d7 2026-05-04 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