Orajel 2x Gum Pain Rinse
NDC Package 10237-799-16

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Orajel 2x Gum Pain (menthol and hydrogen peroxide) rinses is remove imprinted safety seal from bottle capto remove child-resistant cap, squeeze smooth sides of cap while turning. This formulation utilizes a rinse delivery system. Marketed by Church & Dwight Co., Inc., this product is identified by NDC 10237-799 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
10237-799-16
Package Description
473.2 mL in 1 BOTTLE, PLASTIC
Product Code
10237-799
11-Digit Billing Format
10237079916
RxNorm Crosswalk
  • RxCUI: 2584344 - hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical Solution
  • RxCUI: 2584344 - hydrogen peroxide 15 MG/ML / menthol 1 MG/ML Mucous Membrane Topical Solution

Clinical Specifications

Proprietary Name
Orajel 2x Gum Pain Alcohol-free
Non-Proprietary Name
Menthol And Hydrogen Peroxide
Substance Name
Hydrogen Peroxide; Menthol, Unspecified Form
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
Remove imprinted safety seal from bottle capto remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed.Adults and children 2 years of age and olderSwish one-half capful (2 teaspoons = 10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare providerChildren under 12 years of ageShould be supervised in the use of this productChildren under 2 years of ageConsult a dentist or healthcare provider

Regulatory & Marketing

Labeler Name
Church & Dwight Co., Inc.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-15-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10237-799-16 identifies a specific commercial package of 473.2 ml in 1 bottle, plastic of Orajel 2x Gum Pain Alcohol-free, a human over the counter drug labeled by Church & Dwight Co., Inc.. This rinse is formulated for oral use and contains hydrogen peroxide; menthol, unspecified form as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Church & Dwight Co., Inc. on January 15, 2023. The current certification is valid through December 31, 2026.

How is this Church & Dwight Co., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10237079916. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
10237-799-16
11-Digit CMS (5-4-2)
10237-0799-16

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.