Magnificent Menthol Cooling Pain Cream
NDC Package 76348-421-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Magnificent Menthol Cooling Pain Cream is adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physicial or occupational therapistchildren under 12 years of age: contact physical or occupational therapist. Marketed by Renu Laboratories, Inc., this product is identified by NDC 76348-421 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
76348-421-01
Package Description
112 g in 1 JAR
Product Code
11-Digit Billing Format
76348042101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Magnificent Menthol Cooling Pain Cream
Dosage Form
-
Usage Information
Adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physicial or occupational therapistchildren under 12 years of age: contact physical or occupational therapist

Regulatory & Marketing

Labeler Name
Renu Laboratories, 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
12-06-2018
Listing Expiration
12-31-2023
Exclude Flag
I
Sample Package
No

Hierarchy Structure

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 (76348-421). Click a package code to view its specific billing and regulatory data.

112 g in 1 BOX

* 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 76348-421-01 identifies a specific commercial package of 112 g in 1 jar of Magnificent Menthol Cooling Pain Cream, labeled by Renu Laboratories, 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 Renu Laboratories, Inc. on December 06, 2018. The current certification is valid through December 31, 2023.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76348042101. 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)
76348-421-01
11-Digit CMS (5-4-2)
76348-0421-01

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