Hielo Ardiente Gel
NDC Package 53145-002-01

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

Package Information

Hielo Ardiente (menthol) gel is a human otc drug administered via topical route. This formulation utilizes a gel delivery system. Marketed by Menper Distributors, Inc., this product is identified by NDC 53145-002 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
53145-002-01
Package Description
454 g in 1 JAR
Product Code
53145-002
11-Digit Billing Format
53145000201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hielo Ardiente
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 1 g/100g

Regulatory & Marketing

Labeler Name
Menper Distributors, Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-21-2012
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 53145-002-01 identifies a specific commercial package of 454 g in 1 jar of Hielo Ardiente, a human over the counter drug labeled by Menper Distributors, 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 Menper Distributors, Inc. on February 21, 2012. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53145000201. 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)
53145-002-01
11-Digit CMS (5-4-2)
53145-0002-01

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