4x Medicated Toothache And Gum Gel Gel, Dentifrice
NDC Package 56062-312-22

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

Package Information

4x Medicated Toothache And Gum Gel (benzocaine) gel is temporary relief of pain due to toothache * to help protect against infection of minor oral irritation. This formulation utilizes a gel, dentifrice delivery system. Marketed by Publix Super Markets Inc, this product is identified by NDC 56062-312 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
56062-312-22
Package Description
1 TUBE in 1 CARTON / 7 g in 1 TUBE
Product Code
56062-312
11-Digit Billing Format
56062031222
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
4x Medicated Toothache And Gum Gel
Non-Proprietary Name
Benzocaine
Substance Name
Benzalkonium Chloride; Benzocaine; Menthol; Zinc Chloride
Dosage Form
Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Temporary relief of pain due to toothache * to help protect against infection of minor oral irritation

Regulatory & Marketing

Labeler Name
Publix Super Markets Inc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-01-2024
Listing Expiration
12-31-2027
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 56062-312-22 identifies a specific commercial package of 1 tube in 1 carton / 7 g in 1 tube of 4x Medicated Toothache And Gum Gel, a human over the counter drug labeled by Publix Super Markets Inc. This gel, dentifrice is formulated for oral use and contains benzalkonium chloride; benzocaine; menthol; 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 Publix Super Markets Inc on September 01, 2024. The current certification is valid through December 31, 2027.

How is this Publix Super Markets Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 56062031222. 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)
56062-312-22
11-Digit CMS (5-4-2)
56062-0312-22

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