Mag 5 Pt Warming Formula Cream
NDC Package 76348-511-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Mag 5 Pt Warming Formula (menthol) cream is for temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments. This formulation utilizes a cream delivery system. Marketed by Renu Laboratories, Llc, this product is identified by NDC 76348-511 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
76348-511-05
Package Description
1 JAR in 1 BOX / 112 g in 1 JAR (76348-511-04)
Product Code
76348-511
11-Digit Billing Format
76348051105

Clinical Specifications

Proprietary Name
Mag 5 Pt Warming Formula
Non-Proprietary Name
Menthol
Substance Name
Menthol
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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 5.6 g/112g
Usage Information
For temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

Regulatory & Marketing

Labeler Name
Renu Laboratories, Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-19-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76348-511-05 identifies a specific commercial package of 1 jar in 1 box / 112 g in 1 jar (76348-511-04) of Mag 5 Pt Warming Formula, a human over the counter drug labeled by Renu Laboratories, Llc. This cream 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 Renu Laboratories, Llc on March 19, 2019. The current certification is valid through December 31, 2026.

How is this Renu Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76348051105. 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)
76348-511-05
11-Digit CMS (5-4-2)
76348-0511-05

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