Bronson Soothe Pain Relief Cream
NDC Package 83158-387-04

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

Package Information

Bronson Soothe Pain Relief (capsaicin) cream is apply directly to affected area. This formulation utilizes a cream delivery system. Marketed by Bronson Nutritionals, Llc, this product is identified by NDC 83158-387 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
83158-387-04
Package Description
118 mL in 1 TUBE
Product Code
83158-387
11-Digit Billing Format
83158038704
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bronson Soothe Pain Relief
Non-Proprietary Name
Capsaicin
Substance Name
Capsaicin
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)
CAPSAICIN .25 mg/mL
Usage Information
Apply directly to affected area. Do not use more than four times per day.

Regulatory & Marketing

Labeler Name
Bronson Nutritionals, Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-26-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (83158-387). Click a package code to view its specific billing and regulatory data.

83158-387-02
59 mL in 1 TUBE

* 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 83158-387-04 identifies a specific commercial package of 118 ml in 1 tube of Bronson Soothe Pain Relief, a human over the counter drug labeled by Bronson Nutritionals, Llc. This cream 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 Bronson Nutritionals, Llc on December 26, 2022. The current certification is valid through December 31, 2026.

How is this Bronson Nutritionals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83158038704. 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)
83158-387-04
11-Digit CMS (5-4-2)
83158-0387-04

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