Ice Quake
NDC Package 53113-688-05

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.

Ice Quake is a . Marketed by Gadal Laboratories Inc, this product is identified by NDC 53113-688 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
53113-688-05
Package Description
60 g in 1 TUBE
Product Code
53113-688
11-Digit Billing Format
53113068805
RxNorm Crosswalk
  • RxCUI: 1438766 - methyl salicylate 8 % / menthol 2 % Topical Cream
  • RxCUI: 1438766 - menthol 20 MG/ML / methyl salicylate 80 MG/ML Topical Cream

Clinical Specifications

Proprietary Name
Ice Quake White
Dosage Form
-

Regulatory & Marketing

Labeler Name
Gadal Laboratories Inc
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
01-01-2013
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 53113-688-05 identifies a specific commercial package of 60 g in 1 tube of Ice Quake White, labeled by Gadal Laboratories 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 Gadal Laboratories Inc on January 01, 2013. The current certification is valid through December 31, 2017.

How is this Gadal Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53113068805. 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)
53113-688-05
11-Digit CMS (5-4-2)
53113-0688-05

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