Icequake Coldn Hot Medicated Patch Cloth
NDC Package 69822-014-04

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

Package Information

Icequake Coldn Hot Medicated Patch (menthol) cloths is adults and children over 12 years:Carefully remove backing film from patchApply one patch to affected areaUse one patch at a time, 1 or 2 times a dayChildren under 12 years of age:store at room temperature. This formulation utilizes a cloth delivery system. Marketed by Southern Sales & Service, Inc., this product is identified by NDC 69822-014 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
69822-014-04
Package Description
4 PATCH in 1 POUCH / 9.5 g in 1 PATCH
Product Code
69822-014
11-Digit Billing Format
69822001404
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Icequake Coldn Hot Medicated Patch
Non-Proprietary Name
Menthol
Substance Name
Menthol
Dosage Form
Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
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 50 mg/g
Usage Information
Adults and children over 12 years:Carefully remove backing film from patchApply one patch to affected areaUse one patch at a time, 1 or 2 times a dayChildren under 12 years of age:store at room temperature

Regulatory & Marketing

Labeler Name
Southern Sales & Service, Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-02-2022
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 69822-014-04 identifies a specific commercial package of 4 patch in 1 pouch / 9.5 g in 1 patch of Icequake Coldn Hot Medicated Patch, a human over the counter drug labeled by Southern Sales & Service, Inc.. This cloth 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 Southern Sales & Service, Inc. on November 02, 2022. The current certification is valid through December 31, 2026.

How is this Southern Sales & Service, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69822001404. 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)
69822-014-04
11-Digit CMS (5-4-2)
69822-0014-04

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