Home NDC 10237-799 Orajel 2x Gum Pain
Product NDC 10237-799
11-digit product format 102370799
Labeler code 10237
Product ID 10237-799_27eb6e9e-5cd7-d08a-e063-6394a90ad5b6
Type HUMAN OTC DRUG
Nonproprietary name Menthol and Hydrogen Peroxide
Dosage form RINSE
Route ORAL
Labeler Church & Dwight Co., Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-15
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 2x Gum Pain
Brand name suffix Alcohol-Free
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10237-799-16 Orajel 2x Gum Pain Alcohol-Free 473.2 mL in 1 BOTTLE, PLASTIC RINSE 473.2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-799 ORAJEL 2X GUM PAIN ALCOHOL-FREE (MENTHOL AND HYDROGEN PEROXIDE) RINSE [CHURCH & DWIGHT CO., INC.] 2 Current NDC, 1 package rows 20241129_adf37010-922c-4441-93d6-1e1a95025e90.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 24 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10237-799-16 10237079916 473.2 mL in 1 BOTTLE, PLASTIC (10237-799-16) 473.2 ml 2023-01-15 No No Current