Avedana Cool Hot Ice Gel
NDC Package 43749-321-08

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

Package Information

Avedana Cool Hot Ice (menthol) gel is -Adult and children 2 years of age and older. This formulation utilizes a gel delivery system. Marketed by Unipack, Inc., this product is identified by NDC 43749-321 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
43749-321-08
Package Description
227 g in 1 JAR
Product Code
43749-321
11-Digit Billing Format
43749032108
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Avedana Cool Hot Ice
Non-Proprietary Name
Menthol
Substance Name
Menthol
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)
MENTHOL 2 g/100g
Usage Information
-Adult and children 2 years of age and older.  Clean skin thoroughly.  Apply liberally to affected area no more than 3-4 times daily.  No protective cover needed.-May be used with ice packs-May be used with wet or dry bandages, but wrap loosely-Children under 2 years of age, consult a doctor

Regulatory & Marketing

Labeler Name
Unipack, Inc.
Product Type
Human Otc Drug
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
11-04-2017
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 43749-321-08 identifies a specific commercial package of 227 g in 1 jar of Avedana Cool Hot Ice, a human over the counter drug labeled by Unipack, Inc.. This gel is formulated for topical use and contains menthol 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 Unipack, Inc. on November 04, 2017. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43749032108. 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)
43749-321-08
11-Digit CMS (5-4-2)
43749-0321-08

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