Smartrx Natural Pain Relief Sleeve Wrist
NDC Package 60589-005-01

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

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

Smartrx Natural Pain Relief Sleeve Wrist is open pouch and remove. Marketed by Niche Brands, Inc., this product is identified by NDC 60589-005 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
60589-005-01
Package Description
1 PACKAGE in 1 BOX / .2 g in 1 PACKAGE
Product Code
60589-005
11-Digit Billing Format
60589000501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Smartrx Natural Pain Relief Sleeve Wrist
Dosage Form
-
Usage Information
Open pouch and remove. Pull woven sleeve containing external analgesic pads over ankle, positioning on either side of affected area.Adults and children 3 years of age and older: Apply to the affected area not more than 3 to 4 times daily.Children under 3 years of age: Consult a physician.

Regulatory & Marketing

Labeler Name
Niche Brands, 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
12-27-2013
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (60589-005). Click a package code to view its specific billing and regulatory data.

60589-005-00
1 PACKAGE in 1 BOX / .2 g in 1 PACKAGE

* 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 60589-005-01 identifies a specific commercial package of 1 package in 1 box / .2 g in 1 package of Smartrx Natural Pain Relief Sleeve Wrist, labeled by Niche Brands, 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 Niche Brands, Inc. on December 27, 2013. The current certification is valid through December 31, 2017.

How is this Niche Brands, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60589000501. 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)
60589-005-01
11-Digit CMS (5-4-2)
60589-0005-01

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