Point Relief Cold Spot Pain Relieving Gel
NDC Package 51452-035-01

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

Point Relief Cold Spot Pain Relieving (menthol) gel is apply directly to affected area. This formulation utilizes a gel delivery system. Marketed by Fabrication Enterprises, this product is identified by NDC 51452-035 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
51452-035-01
Package Description
120 mL in 1 BOTTLE
Product Code
51452-035
11-Digit Billing Format
51452003501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Point Relief Cold Spot Pain Relieving
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 120 mg/mL
Usage Information
Apply directly to affected area. Do not use more than four fimes per day.

Regulatory & Marketing

Labeler Name
Fabrication Enterprises
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2019
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 (51452-035). Click a package code to view its specific billing and regulatory data.

51452-035-02
475 mL in 1 BOTTLE
51452-035-03
3800 mL in 1 JUG
51452-035-04
420 mL in 1 TUBE
51452-035-05
950 mL in 1 BOTTLE

* 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 51452-035-01 identifies a specific commercial package of 120 ml in 1 bottle of Point Relief Cold Spot Pain Relieving, a human over the counter drug labeled by Fabrication Enterprises. 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 Fabrication Enterprises on April 01, 2019. The current certification is valid through December 31, 2026.

How is this Fabrication Enterprises product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51452003501. 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)
51452-035-01
11-Digit CMS (5-4-2)
51452-0035-01

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