Biosavia External Analgesic Pain Relief Gel
NDC Package 84680-529-00

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

Package Information

Biosavia External Analgesic Pain Relief (capsaicin) gel is adults and children 2 years of age and older apply liberally onto affected area not more than 3 to 4 times dailyMassage evenly where needed until the gel is fully absorbed Massage your feet for a better sleepFor a craneal massage, use on your head from your neck to your temples pressing all over your scalpmassage on afected area for physical fatigue, swollen feet and legs. This formulation utilizes a gel delivery system. Marketed by Biosavia Usa, Llc, this product is identified by NDC 84680-529 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
84680-529-00
Package Description
117.5 g in 1 BOTTLE
Product Code
84680-529
11-Digit Billing Format
84680052900
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Biosavia External Analgesic Pain Relief
Non-Proprietary Name
Capsaicin
Substance Name
Capsaicin
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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)
CAPSAICIN .25 mg/g
Usage Information
Adults and children 2 years of age and older apply liberally onto affected area not more than 3 to 4 times dailyMassage evenly where needed until the gel is fully absorbed Massage your feet for a better sleepFor a craneal massage, use on your head from your neck to your temples pressing all over your scalpmassage on afected area for physical fatigue, swollen feet and legs

Regulatory & Marketing

Labeler Name
Biosavia Usa, Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-19-2024
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 84680-529-00 identifies a specific commercial package of 117.5 g in 1 bottle of Biosavia External Analgesic Pain Relief, a human over the counter drug labeled by Biosavia Usa, Llc. This gel is formulated for topical use and contains capsaicin 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 Biosavia Usa, Llc on August 19, 2024. The current certification is valid through December 31, 2026.

How is this Biosavia Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84680052900. 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)
84680-529-00
11-Digit CMS (5-4-2)
84680-0529-00

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