Australian Dream Power 4 Muscle And Joint Pain Relief Cream
NDC Package 61577-8220-4

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.

Australian Dream Power 4 Muscle And Joint Pain Relief Cream is ​For use by adults 18 years of age and older. Marketed by Sombra Cosmetics, Inc., this product is identified by NDC 61577-8220 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
61577-8220-4
Package Description
119 g in 1 JAR
Product Code
61577-8220
11-Digit Billing Format
61577822004

Clinical Specifications

Proprietary Name
Australian Dream Power 4 Muscle And Joint Pain Relief Cream
Dosage Form
-
Usage Information
​For use by adults 18 years of age and older. ​Apply a thin layer to affected area not more than 3 to 4 times daily. Wash hands with soap or dishwashing liquid after application. If using on hands, allow 30 minutes for absorption before washing hands. Massage intopainful area until thoroughly absorbed into skin. ​Children under 18 years consult a physician. ​Store between 40F and 86F (4C and 30C), Tamper Evident Feature: do not use if outer shrink wrap on jar is torn, broken or missing.

Regulatory & Marketing

Labeler Name
Sombra Cosmetics, 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
05-10-2023
Listing Expiration
12-31-2024
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 61577-8220-4 identifies a specific commercial package of 119 g in 1 jar of Australian Dream Power 4 Muscle And Joint Pain Relief Cream, labeled by Sombra Cosmetics, 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 Sombra Cosmetics, Inc. on May 10, 2023. The current certification is valid through December 31, 2024.

How is this Sombra Cosmetics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61577822004. 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)
61577-8220-4
11-Digit CMS (5-4-2)
61577-8220-04

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