3x Medicated Toothache And Gum Gel
NDC Package 11822-0613-9

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

Package Information

3x Medicated Toothache And Gum Gel (benzocaine) gel is methemoglobinemia warning: use of this product may cause methemoglobinema, a serious condition that must be treated promptly because it reduces the amount of oxygen in the blood. This formulation utilizes a gel delivery system. Marketed by Rite Aid, this product is identified by NDC 11822-0613 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
11822-0613-9
Package Description
1 TUBE in 1 CARTON / 11.7 g in 1 TUBE
Product Code
11822-0613
11-Digit Billing Format
11822061309
RxNorm Crosswalk
  • RxCUI: 2362013 - benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Gel
  • RxCUI: 2362013 - benzocaine 0.2 MG/MG / menthol 0.0026 MG/MG / zinc chloride 0.0015 MG/MG Oral Gel

Clinical Specifications

Proprietary Name
3x Medicated Toothache And Gum Gel
Non-Proprietary Name
Benzocaine
Substance Name
Benzocaine; Menthol; 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
Methemoglobinemia warning: use of this product may cause methemoglobinema, a serious condition that must be treated promptly because it reduces the amount of oxygen in the blood. This can occur even if you have used this prouct before. Stop use and seek immediate medical attention if you or a child in your care develops: * pale, gray, or blue colored skin (cyanosis) * headache * rapid heart rate * shortness of breath * dizziness or lightheadedness * fatigue or lack of energy

Regulatory & Marketing

Labeler Name
Rite Aid
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-06-2020
End Marketing Date
11-01-2027
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 11822-0613-9 identifies a specific commercial package of 1 tube in 1 carton / 11.7 g in 1 tube of 3x Medicated Toothache And Gum Gel, a human over the counter drug labeled by Rite Aid. This gel is formulated for oral use and contains 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 Rite Aid on May 06, 2020.

How is this Rite Aid product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11822061309. 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 (5-4-1)
11822-0613-9
11-Digit CMS (5-4-2)
11822-0613-09

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