4x Medicated Toothache And Gum Cream
NDC Package 0363-0607-79

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

4x Medicated Toothache And Gum Cream (benzocaine) cream is cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. This formulation utilizes a cream delivery system. Marketed by Walgreens, this product is identified by NDC 0363-0607 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
0363-0607-79
Package Description
1 TUBE in 1 CARTON / 9.4 g in 1 TUBE
Product Code
0363-0607
11-Digit Billing Format
00363060779
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
4x Medicated Toothache And Gum Cream
Non-Proprietary Name
Benzocaine
Substance Name
Benzalkonium Chloride; Benzocaine; Menthol, Unspecified Form; Zinc Chloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor * children under 12 years of age should be supervised in the use of this product * children under 2 years of age: do not use

Regulatory & Marketing

Labeler Name
Walgreens
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-02-2020
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 (0363-0607). Click a package code to view its specific billing and regulatory data.

0363-0607-19
1 TUBE in 1 CARTON / 14 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 0363-0607-79 identifies a specific commercial package of 1 tube in 1 carton / 9.4 g in 1 tube of 4x Medicated Toothache And Gum Cream, a human over the counter drug labeled by Walgreens. This cream is formulated for oral use and contains benzalkonium chloride; benzocaine; menthol, unspecified form; zinc chloride 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 Walgreens on June 02, 2020. The current certification is valid through December 31, 2026.

How is this Walgreens product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00363060779. 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 (4-4-2)
0363-0607-79
11-Digit CMS (5-4-2)
00363-0607-79

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