Home NDC 10237-784-16 Orajel Antiseptic Alcohol-Free Mouth Sore Rinse
Product NDC 10237-784
Requested package NDC 10237-784-16
11-digit product format 102370784
Labeler code 10237
Product ID 10237-784_27ea6bc8-f26b-d947-e063-6394a90ae2f5
Type HUMAN OTC DRUG
Nonproprietary name Hydrogen peroxide, Menthol
Dosage form LIQUID
Route ORAL
Labeler Church & Dwight Co., Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-01
Substance MENTHOL, UNSPECIFIED FORM; HYDROGEN PEROXIDE
Active strength 1; 15 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Antiseptic Alcohol-Free Mouth Sore Rinse
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 1 mg/mL HYDROGEN PEROXIDE 15 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup BBX060AN9V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2584344 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10237-784-16 Orajel Antiseptic Alcohol-Free Mouth Sore Rinse 473.2 mL in 1 BOTTLE LIQUID 473.2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-784 ORAJEL ANTISEPTIC ALCOHOL-FREE MOUTH SORE RINSE (HYDROGEN PEROXIDE, MENTHOL) LIQUID [CHURCH & DWIGHT CO., INC.] 6 Current NDC, Legacy NDC, 1 package rows 20241129_99d47d6a-fa2e-d5ee-e053-2995a90aa11d.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 40 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Iolite BENZOCAINE Dharma Research, Inc. e4b2d22b-00b3-45a6-9b7d-8ee719587059 2023-10-09 Warnings Exact identifier application number: M022 Iolite BENZOCAINE Dharma Research, Inc. a0e284f6-292f-4231-8596-f7cee4e0a12f 2023-10-09 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC fe92637a-c88a-f9dd-e053-6294a90a7fa3 2023-07-01 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC c979e958-2042-471a-bf03-e84e68620106 2023-06-20 Warnings Exact identifier application number: M022 Orajel Gum Pain 3X Medicated BENZOCAINE, MENTHOL, ZINC CHLORIDE Church & Dwight Co., Inc. 9a1632ad-2b47-5653-e053-2995a90ae0d9 2023-01-20 Warnings Exact identifier application number: M022 KOLORZ TOPICAL ANESTHETIC TRIPLE MINT BENZOCAINE DMG AMERICA, LLC 0f90b227-f938-4e1a-a79e-1967b1a0477e 2021-10-01 Warnings Exact identifier application number: M022
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10237-784-16 10237078416 473.2 mL in 1 BOTTLE (10237-784-16) 473.2 ml 2019-11-01 0000-00-00 No No Current