Emu Therapy Red Hot Pepper Pain Relief Cream
NDC Package 83591-417-00

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

Package Information

Emu Therapy Red Hot Pepper Pain Relief Cream (menthol, capsaicin) cream is for adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. This formulation utilizes a cream delivery system. Marketed by Aca Management Llc, this product is identified by NDC 83591-417 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
83591-417-00
Package Description
237 mL in 1 JAR
Product Code
83591-417
11-Digit Billing Format
83591041700
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Emu Therapy Red Hot Pepper Pain Relief Cream
Non-Proprietary Name
Menthol, Capsaicin
Substance Name
Capsaicin; 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)
Usage Information
For adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. Consult a doctor before using for children under 2 years of age.

Regulatory & Marketing

Labeler Name
Aca Management Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-08-2023
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 83591-417-00 identifies a specific commercial package of 237 ml in 1 jar of Emu Therapy Red Hot Pepper Pain Relief Cream, a human over the counter drug labeled by Aca Management Llc. This cream is formulated for topical use and contains capsaicin; 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 Aca Management Llc on August 08, 2023. The current certification is valid through December 31, 2026.

How is this Aca Management Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83591041700. 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)
83591-417-00
11-Digit CMS (5-4-2)
83591-0417-00

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