Orajel 2x Medicated Gel
NDC Package 10237-782-25

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

Package Information

Orajel 2x Medicated Gel (oral pain reliever) gel is cut open tip of tube on score markAdults and children 2 years of age and over: apply to affected area up to 4 times daily or as directed by a dentist or doctorChildren between 2 and 12 years of age: ask a doctor before use. This formulation utilizes a gel delivery system. Marketed by Church & Dwight Co., Inc., this product is identified by NDC 10237-782 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
10237-782-25
Package Description
1 TUBE in 1 CARTON / 7 g in 1 TUBE
Product Code
10237-782
11-Digit Billing Format
10237078225
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Orajel 2x Medicated Gel
Non-Proprietary Name
Oral Pain Reliever
Substance Name
Benzocaine; Menthol
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Cut open tip of tube on score markAdults and children 2 years of age and over: apply to affected area up to 4 times daily or as directed by a dentist or doctorChildren between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product. Children under 2 years of age: do not use

Regulatory & Marketing

Labeler Name
Church & Dwight Co., Inc.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-23-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10237-782). Click a package code to view its specific billing and regulatory data.

10237-782-42
1 TUBE in 1 PACKAGE / 4.2 g in 1 TUBE

* 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 10237-782-25 identifies a specific commercial package of 1 tube in 1 carton / 7 g in 1 tube of Orajel 2x Medicated Gel, a human over the counter drug labeled by Church & Dwight Co., Inc.. This gel is formulated for topical use and contains benzocaine; menthol 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 May 23, 2022. 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: 10237078225. 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)
10237-782-25
11-Digit CMS (5-4-2)
10237-0782-25

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