Teds Topical Pain Gel Roll On
NDC Package 58133-211-03

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.

Teds Topical Pain Gel Roll On is use only as directed​Adults and children over 2 years:Apply generously to affected areamassage into painful area until thoroughly absorbedinto skinrepeat as necessary, but no more than 3 to 4 times dailychildren under 2 years of age: Ask a doctor. Marketed by Cosmetic Specialty Labs, Inc., this product is identified by NDC 58133-211 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
58133-211-03
Package Description
85 g in 1 TUBE, WITH APPLICATOR
Product Code
58133-211
11-Digit Billing Format
58133021103
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Teds Topical Pain Gel Roll On
Dosage Form
-
Usage Information
Use only as directed​Adults and children over 2 years:Apply generously to affected areamassage into painful area until thoroughly absorbedinto skinrepeat as necessary, but no more than 3 to 4 times dailychildren under 2 years of age: Ask a doctor

Regulatory & Marketing

Labeler Name
Cosmetic Specialty Labs, 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
03-21-2019
Listing Expiration
12-31-2023
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 58133-211-03 identifies a specific commercial package of 85 g in 1 tube, with applicator of Teds Topical Pain Gel Roll On, labeled by Cosmetic Specialty Labs, 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 Cosmetic Specialty Labs, Inc. on March 21, 2019. The current certification is valid through December 31, 2023.

How is this Cosmetic Specialty Labs, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58133021103. 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)
58133-211-03
11-Digit CMS (5-4-2)
58133-0211-03

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