Green Remedy Cooling Roll On
NDC Package 78461-0002-1

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.

Green Remedy Cooling Roll On is temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, sprains, and bruises.Shake well before use. Marketed by Exclave Holdings Inc., this product is identified by NDC 78461-0002 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
78461-0002-1
Package Description
1 g in 1 BOTTLE, WITH APPLICATOR
Product Code
78461-0002
11-Digit Billing Format
78461000201

Clinical Specifications

Proprietary Name
Green Remedy Cooling Roll On
Dosage Form
-
Usage Information
Temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, sprains, and bruises.Shake well before use. Apply liberally to affected area. No need to rub in. Repeat if necessary, no more than 4 times daily. Rinse with soap and water to remove. Wash hands with soap and water after use. For children under 12 years of age, consult a physician.

Regulatory & Marketing

Labeler Name
Exclave Holdings 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
03-30-2020
Listing Expiration
12-31-2022
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 78461-0002-1 identifies a specific commercial package of 1 g in 1 bottle, with applicator of Green Remedy Cooling Roll On, labeled by Exclave Holdings 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 Exclave Holdings Inc. on March 30, 2020. The current certification is valid through December 31, 2022.

How is this Exclave Holdings Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78461000201. 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)
78461-0002-1
11-Digit CMS (5-4-2)
78461-0002-01

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