Orajel 4x Medicated For Toothache And Gum, Cream
NDC Package 10237-788-33

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

Package Information

Orajel 4x Medicated For Toothache And Gum, Cream (benzalkonium chloride, benzocaine, menthol, zinc chloride) cream is adults and children 2 years of age and olderApply to affected area up to 4 times daily or as directed by a dentist or doctorChildren between 2 and 12 years of ageAsk a doctor before use. This formulation utilizes a cream delivery system. Marketed by Church & Dwight Co., Inc., this product is identified by NDC 10237-788 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
10237-788-33
Package Description
1 TUBE in 1 CARTON / 9.4 g in 1 TUBE
Product Code
10237-788
11-Digit Billing Format
10237078833
RxNorm Crosswalk
  • RxCUI: 2370903 - benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Cream
  • RxCUI: 2370903 - benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral Cream

Clinical Specifications

Proprietary Name
Orajel 4x Medicated For Toothache And Gum, Cream
Non-Proprietary Name
Benzalkonium Chloride, Benzocaine, Menthol, Zinc Chloride
Substance Name
Benzalkonium Chloride; Benzocaine; Menthol, Unspecified Form; Zinc Cation
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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
Adults and children 2 years of age and olderApply to affected area up to 4 times daily or as directed by a dentist or doctorChildren between 2 and 12 years of ageAsk a doctor before use. Should be supervised in the use of this productChildren under 2 years of ageDo 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
11-01-2019
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 10237-788-33 identifies a specific commercial package of 1 tube in 1 carton / 9.4 g in 1 tube of Orajel 4x Medicated For Toothache And Gum, Cream, a human over the counter drug labeled by Church & Dwight Co., Inc.. This cream is formulated for topical use and contains benzalkonium chloride; benzocaine; menthol, unspecified form; zinc cation 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 November 01, 2019. 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: 10237078833. 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)
10237-788-33
11-Digit CMS (5-4-2)
10237-0788-33

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