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 73 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CVS Cold and Hot MENTHOL CVS Pharmacy a44cec95-822a-40b6-e053-2995a90ae31c 2025-10-17 Warnings Exact identifier application number: M017 Sombra Max SOMBRA MAX Sombra Cosmetics Inc. 41623a46-e6e7-907e-e063-6394a90afc4c 2025-10-17 Warnings Exact identifier application number: M017 POMADA DRAGON PAIN RELIEVING CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE TELEVISA CONSUMER PRODUCTS USA c283291d-feaa-4f89-8fde-9e3957ea8b9f 2025-10-17 Warnings Exact identifier application number: M017 Ear Pain MD LIDOCAINE HYDROCHLORIDE Eosera Inc 78c4418f-7f0f-447f-a94f-d4c89a081af1 2025-10-17 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 414217c1-ff3a-b556-e063-6394a90aa5db 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 41422d04-160b-51b2-e063-6294a90ab2b2 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 41427275-4c35-bbdf-e063-6294a90a14cf 2025-10-16 Warnings Exact identifier application number: M017 Dollar General Menthol Pain Relief Gel Rollon MENTHOL Dolgencorp, LLC 3a9b99e2-36b8-5dcf-e063-6394a90a382d 2025-10-16 Warnings Exact identifier application number: M017 Quality Choice HYDROCORTISONE Chain Drug Marketing Association, Inc. 24c3eb99-92ac-658c-e063-6394a90ab51f 2025-10-16 Warnings Exact identifier application number: M017 DentiCalm TOPICAL ANALGESIC NFUSE LLC 414e6f6f-06bb-b470-e063-6294a90af390 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 413008cd-d239-1453-e063-6394a90a74f2 2025-10-15 Warnings Exact identifier application number: M017 PERFORM LEO EXTENSIVE PAIN RELIEF LIDOCAINE, MENTHOL PERFORM LEO LLC f993ed5f-7dbb-4e3e-addf-f65b12f5cc48 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Lower Leg Sleeve CAPSAICIN Nufabrx LLC b8e3e528-b7cd-e4b7-e053-2995a90a4029 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Medicine Infused Ankle Sleeve CAPSAICIN Nufabrx LLC 013d60c7-a613-7cdf-e063-6294a90ad584 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Calf Sleeve CAPSAICIN Nufabrx LLC bd9459c4-5596-746f-e053-2995a90a5400 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Arm Sleeve CAPSAICIN Nufabrx LLC a7993eaf-6488-a818-e053-2995a90a7ea6 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Back Wrap CAPSAICIN Nufabrx LLC e4f85ac8-57cb-46eb-e053-2995a90a9b1c 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Medicine Infused Socks CAPSAICIN Nufabrx LLC 013cb66f-8695-b69f-e063-6294a90a699c 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Neck Wrap CAPSAICIN Nufabrx LLC e10b420c-500d-5738-e053-2a95a90a008f 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Knee Sleeve CAPSAICIN Nufabrx LLC a5f455d4-5fc5-d516-e053-2a95a90a921e 2025-10-15 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