Anbesol Gel
NDC Package 80070-220-33

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

Package Information

Anbesol (benzocaine) gel is to open tube, cut tip of the tube on score mark with scissors adults and children 2 years of age and overapply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentistchildren under 12 years of ageadult supervision should be given in the use of this productchildren under 2 years of agedo not usefor denture irritation:apply thin layer to the affected areado not reinsert dental work until irritation/pain is relievedrinse mouth well before reinserting. This formulation utilizes a gel delivery system. Marketed by Foundation Consumer Brands, this product is identified by NDC 80070-220 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
80070-220-33
Package Description
1 TUBE in 1 BLISTER PACK / 9 g in 1 TUBE
Product Code
80070-220
11-Digit Billing Format
80070022033
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Anbesol Maximum Strength
Non-Proprietary Name
Benzocaine
Substance Name
Benzocaine
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
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)
BENZOCAINE 200 mg/g
Pharmacologic Class
Usage Information
To open tube, cut tip of the tube on score mark with scissors adults and children 2 years of age and overapply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentistchildren under 12 years of ageadult supervision should be given in the use of this productchildren under 2 years of agedo not usefor denture irritation:apply thin layer to the affected areado not reinsert dental work until irritation/pain is relievedrinse mouth well before reinserting

Regulatory & Marketing

Labeler Name
Foundation Consumer Brands
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-15-2021
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 80070-220-33 identifies a specific commercial package of 1 tube in 1 blister pack / 9 g in 1 tube of Anbesol Maximum Strength, a human over the counter drug labeled by Foundation Consumer Brands. This gel is formulated for topical use and contains benzocaine 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 Foundation Consumer Brands on September 15, 2021. The current certification is valid through December 31, 2026.

How is this Foundation Consumer Brands product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80070022033. 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)
80070-220-33
11-Digit CMS (5-4-2)
80070-0220-33

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