Dibucaine Ointment
NDC Package 71399-2829-2

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

Package Information

Dibucaine ointment is not for prolonged useAdults should not use more than 1oz in 24 hours or 1/4 oz for childApply to affected area 3 or 4 times dailyCover with light dressing, if necessary. This formulation utilizes a ointment delivery system. Marketed by Akron Pharma Inc., this product is identified by NDC 71399-2829 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
71399-2829-2
Package Description
1 TUBE in 1 PACKAGE / 56 g in 1 TUBE
Product Code
71399-2829
11-Digit Billing Format
71399282902
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
56 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dibucaine
Non-Proprietary Name
Dibucaine
Substance Name
Dibucaine
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
DIBUCAINE .28 g/28g
Pharmacologic Class
Usage Information
Not for prolonged useAdults should not use more than 1oz in 24 hours or 1/4 oz for childApply to affected area 3 or 4 times dailyCover with light dressing, if necessary

Regulatory & Marketing

Labeler Name
Akron Pharma Inc.
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-06-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71399-2829). Click a package code to view its specific billing and regulatory data.

71399-2829-1
28 g in 1 TUBE

* 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 71399-2829-2 identifies a specific commercial package of 1 tube in 1 package / 56 g in 1 tube of Dibucaine, a human over the counter drug labeled by Akron Pharma Inc.. This product is billed per "GM" gram and contains an estimated amount of 56 billable units per package. This ointment is formulated for topical use and contains dibucaine 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 Akron Pharma Inc. on January 06, 2025. The current certification is valid through December 31, 2026.

How is this Akron Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71399282902. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 56 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)
71399-2829-2
11-Digit CMS (5-4-2)
71399-2829-02

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