Cold And Hot Pain Relief Sleeve
NDC Package 67510-0085-4

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 And Hot Pain Relief Sleeve is adults and children over 12 yearsClean and dry affected area.Cut open pouch and remove Sleeve.Remove the clear plastic insert.Pull Sleeve onto knee, large ankle or elbow.Medication is on the colored section of the Sleeve, so the colored section should be placed on the affected area.Pull Sleeve over itself to make medicine touch directly on your skin.Apply one Sleeve to affected area.Repeat as necessary , but no more than 4 times a day.Sleeve should fit snug, but not tight.Children 12 years or younger: ask a doctor. Marketed by Kareway Product, Inc., this product is identified by NDC 67510-0085 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
67510-0085-4
Package Description
1 POUCH in 1 BOX / 1 PATCH in 1 POUCH
Product Code
67510-0085
11-Digit Billing Format
67510008504
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cold And Hot Pain Relief Sleeve
Dosage Form
-
Usage Information
Adults and children over 12 yearsClean and dry affected area.Cut open pouch and remove Sleeve.Remove the clear plastic insert.Pull Sleeve onto knee, large ankle or elbow.Medication is on the colored section of the Sleeve, so the colored section should be placed on the affected area.Pull Sleeve over itself to make medicine touch directly on your skin.Apply one Sleeve to affected area.Repeat as necessary , but no more than 4 times a day.Sleeve should fit snug, but not tight.Children 12 years or younger: ask a doctor

Regulatory & Marketing

Labeler Name
Kareway Product, 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
04-19-2012
Listing Expiration
12-31-2021
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 67510-0085-4 identifies a specific commercial package of 1 pouch in 1 box / 1 patch in 1 pouch of Cold And Hot Pain Relief Sleeve, labeled by Kareway Product, 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 Kareway Product, Inc. on April 19, 2012. The current certification is valid through December 31, 2021.

How is this Kareway Product, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67510008504. 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 (5-4-1)
67510-0085-4
11-Digit CMS (5-4-2)
67510-0085-04

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