Cold Spot
NDC Package 51452-005-04

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cold Spot is for temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains. Marketed by Fabrication Enterprises, Inc., this product is identified by NDC 51452-005 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
51452-005-04
Package Description
4 mL in 1 TUBE, WITH APPLICATOR
Product Code
51452-005
11-Digit Billing Format
51452000504
RxNorm Crosswalk
  • RxCUI: 1045442 - menthol 12 % / methyl salicylate 4 % Topical Gel
  • RxCUI: 1045442 - menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel
  • RxCUI: 1235996 - ColdSpot POINT RELIEF 12 % / 4 % Topical Gel
  • RxCUI: 1235996 - menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel [Cold Spot with Methyl Salicylate]
  • RxCUI: 1235996 - Cold Spot Point Relief with Methyl Salicylate (menthol 12 % / methyl salicylate 4 % ) Topical Gel

Clinical Specifications

Proprietary Name
Cold Spot Point Relief
Dosage Form
-
Usage Information
For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.

Regulatory & Marketing

Labeler Name
Fabrication Enterprises, Inc.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
10-13-2011
Listing Expiration
12-31-2017
Exclude Flag
I
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 51452-005-04 identifies a specific commercial package of 4 ml in 1 tube, with applicator of Cold Spot Point Relief, labeled by Fabrication Enterprises, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Fabrication Enterprises, Inc. on October 13, 2011. The current certification is valid through December 31, 2017.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51452000504. 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)
51452-005-04
11-Digit CMS (5-4-2)
51452-0005-04

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