Healthy Back Institute Rub On Relief Cream
NDC Package 79804-618-03

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

Package Information

Healthy Back Institute Rub On Relief (analgesic) cream is adults and children 12 years of age and older: Apply to the affected area not more than 3 to 4 times daily. This formulation utilizes a cream delivery system. Marketed by Eagle Labs Inc., this product is identified by NDC 79804-618 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
79804-618-03
Package Description
87.1 g in 1 PACKAGE
Product Code
79804-618
11-Digit Billing Format
79804061803
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Healthy Back Institute Rub On Relief
Non-Proprietary Name
Analgesic
Substance Name
Camphor (synthetic); 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
Adults and children 12 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age consult a doctor.

Regulatory & Marketing

Labeler Name
Eagle Labs Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-03-2024
Listing Expiration
12-31-2027
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 79804-618-03 identifies a specific commercial package of 87.1 g in 1 package of Healthy Back Institute Rub On Relief, a human over the counter drug labeled by Eagle Labs Inc.. This cream is formulated for topical use and contains camphor (synthetic); 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 Eagle Labs Inc. on June 03, 2024. The current certification is valid through December 31, 2027.

How is this Eagle Labs Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79804061803. 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)
79804-618-03
11-Digit CMS (5-4-2)
79804-0618-03

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