Scalar Pain Relief Cream
NDC Package 80883-097-00

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

Package Information

Scalar Pain Relief Cream (menthol) cream is adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: consult a doctor. This formulation utilizes a cream delivery system. Marketed by Miracle Balance, Llc, this product is identified by NDC 80883-097 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
80883-097-00
Package Description
1 JAR in 1 BOX / 59.1 mL in 1 JAR
Product Code
80883-097
11-Digit Billing Format
80883009700
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Scalar Pain Relief Cream
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 50 mg/mL
Usage Information
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: consult a doctor.

Regulatory & Marketing

Labeler Name
Miracle Balance, Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-15-2020
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 80883-097-00 identifies a specific commercial package of 1 jar in 1 box / 59.1 ml in 1 jar of Scalar Pain Relief Cream, a human over the counter drug labeled by Miracle Balance, 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 Miracle Balance, Llc on October 15, 2020. The current certification is valid through December 31, 2026.

How is this Miracle Balance, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80883009700. 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)
80883-097-00
11-Digit CMS (5-4-2)
80883-0097-00

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