Pain Release Granule
NDC Package 69204-005-08

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

Pain Release (menthol) granules is adults and children 12 years of age and older: Apply to affected area by dissolving 2 teaspoons of salt soak in warm water and soaking area. This formulation utilizes a granule delivery system. Marketed by Natures Formulae Health Products Ltd., this product is identified by NDC 69204-005 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
69204-005-08
Package Description
300 g in 1 BOTTLE, PLASTIC
Product Code
69204-005
11-Digit Billing Format
69204000508

Clinical Specifications

Proprietary Name
Pain Release
Non-Proprietary Name
Menthol
Substance Name
Menthol
Dosage Form
Granule - A small particle or grain.
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 1.6 mg/g
Usage Information
Adults and children 12 years of age and older: Apply to affected area by dissolving 2 teaspoons of salt soak in warm water and soaking area

Regulatory & Marketing

Labeler Name
Natures Formulae Health Products Ltd.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-16-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69204-005). Click a package code to view its specific billing and regulatory data.

69204-005-06
620 g in 1 BOTTLE, PLASTIC
69204-005-07
1 POUCH in 1 PACKET / 120 g in 1 POUCH

* 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 69204-005-08 identifies a specific commercial package of 300 g in 1 bottle, plastic of Pain Release, a human over the counter drug labeled by Natures Formulae Health Products Ltd.. This granule 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 Natures Formulae Health Products Ltd. on October 16, 2016. The current certification is valid through December 31, 2026.

How is this Natures Formulae Health Products Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69204000508. 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)
69204-005-08
11-Digit CMS (5-4-2)
69204-0005-08

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