Topco 4x Medicated Toothache And Gum Gel
NDC Package 36800-624-49

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

Package Information

Topco 4x Medicated Toothache And Gum Gel (benzocaine) gel is for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation. This formulation utilizes a gel delivery system. Marketed by Topcare, this product is identified by NDC 36800-624 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
36800-624-49
Package Description
1 TUBE in 1 CARTON / 7 g in 1 TUBE
Product Code
36800-624
11-Digit Billing Format
36800062449
RxNorm Crosswalk
  • RxCUI: 2369638 - benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral Gel
  • RxCUI: 2369638 - benzalkonium chloride 0.0013 MG/MG / benzocaine 0.2 MG/MG / menthol 0.005 MG/MG / zinc chloride 0.0015 MG/MG Oral Gel

Clinical Specifications

Proprietary Name
Topco 4x Medicated Toothache And Gum Gel
Non-Proprietary Name
Benzocaine
Substance Name
Benzalkonium Chloride; Benzocaine; Menthol, Unspecified Form; Zinc Chloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
For the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation

Regulatory & Marketing

Labeler Name
Topcare
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-18-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 36800-624-49 identifies a specific commercial package of 1 tube in 1 carton / 7 g in 1 tube of Topco 4x Medicated Toothache And Gum Gel, a human over the counter drug labeled by Topcare. This gel 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 Topcare on November 18, 2020. The current certification is valid through December 31, 2026.

How is this Topcare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800062449. 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)
36800-624-49
11-Digit CMS (5-4-2)
36800-0624-49

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