Pain Relief Gel-roll On
NDC Package 83016-331-11

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.

Pain Relief Gel-roll On is ■ Adults and children 12 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary■ Children under 12 years of age: Consult Physician. Marketed by R & Y Group, Llc, this product is identified by NDC 83016-331 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
83016-331-11
Package Description
1 BOTTLE in 1 BAG / 74 mL in 1 BOTTLE (83016-331-01)
Product Code
83016-331
11-Digit Billing Format
83016033111
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pain Relief Gel-roll On
Dosage Form
-
Usage Information
■ Adults and children 12 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary■ Children under 12 years of age: Consult Physician

Regulatory & Marketing

Labeler Name
R & Y Group, Llc
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-27-2023
Listing Expiration
12-31-2025
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 (83016-331). Click a package code to view its specific billing and regulatory data.

83016-331-21
3 BOTTLE in 1 BAG / 74 mL in 1 BOTTLE (83016-331-01)

* 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 83016-331-11 identifies a specific commercial package of 1 bottle in 1 bag / 74 ml in 1 bottle (83016-331-01) of Pain Relief Gel-roll On, labeled by R & Y Group, Llc. 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 R & Y Group, Llc on October 27, 2023. The current certification is valid through December 31, 2025.

How is this R & Y Group, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83016033111. 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)
83016-331-11
11-Digit CMS (5-4-2)
83016-0331-11

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