Cetacaine Topical Anesthetic Gel
NDC Package 10223-0221-1

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

Package Information

Cetacaine Topical Anesthetic (benzocaine, butamben, and tetracaine hydrochloride) gel is cetacaine Topical Anesthetic Gel is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. This formulation utilizes a gel delivery system. Marketed by Cetylite Industries, Inc., this product is identified by NDC 10223-0221.

Identification & Billing

NDC Package Code
10223-0221-1
Package Description
1 JAR in 1 BOX / 32 g in 1 JAR
Product Code
10223-0221
11-Digit Billing Format
10223022101
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
32 GM
RxNorm Crosswalk
  • RxCUI: 209970 - Cetacaine 14 % / 2 % / 2 % Topical Gel
  • RxCUI: 209970 - benzocaine 0.14 MG/MG / butamben 0.02 MG/MG / tetracaine 0.02 MG/MG Topical Gel [Cetacaine]
  • RxCUI: 209970 - Cetacaine (benzocaine 14 % / butamben 2 % / tetracaine 2 % ) Topical Gel
  • RxCUI: 308645 - benzocaine 14 % / butamben 2 % / tetracaine 2 % Topical Gel
  • RxCUI: 308645 - benzocaine 0.14 MG/MG / butamben 0.02 MG/MG / tetracaine 0.02 MG/MG Topical Gel

Clinical Specifications

Proprietary Name
Cetacaine Topical Anesthetic
Non-Proprietary Name
Benzocaine, Butamben, And Tetracaine Hydrochloride
Substance Name
Benzocaine; Butamben; Tetracaine Hydrochloride
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)
Pharmacologic Class
Usage Information
Cetacaine Topical Anesthetic Gel is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Cetacaine Topical Anesthetic Gel is indicated for use to control pain and for use for surgical or endoscopic procedures, or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used for vaginal or rectal procedures where feasible.

Regulatory & Marketing

Labeler Name
Cetylite Industries, Inc.
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
01-01-1960
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 10223-0221-1 identifies a specific commercial package of 1 jar in 1 box / 32 g in 1 jar of Cetacaine Topical Anesthetic, a human prescription drug labeled by Cetylite Industries, Inc.. This product is billed per "GM" gram and contains an estimated amount of 32 billable units per package. This gel is formulated for topical use and contains benzocaine; butamben; tetracaine hydrochloride 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 Cetylite Industries, Inc. on January 01, 1960. The current certification is valid through December 31, 2026.

How is this Cetylite Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10223022101. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 32 total billable units per package. 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)
10223-0221-1
11-Digit CMS (5-4-2)
10223-0221-01

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