Broda Acne Spa
NDC Package 54111-111-50

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.

Broda Acne Spa is clean the skin thoroughly before applying this product.Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily.Because excessive drying of the skin may occur, start  with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Marketed by Bentley Laboratories, Llc, this product is identified by NDC 54111-111 and is authorized under FDA application part333D.

Identification & Billing

NDC Package Code
54111-111-50
Package Description
100 g in 1 TUBE
Product Code
54111-111
11-Digit Billing Format
54111011150
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Broda Acne Spa
Dosage Form
-
Usage Information
Clean the skin thoroughly before applying this product.Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily.Because excessive drying of the skin may occur, start  with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Regulatory & Marketing

Labeler Name
Bentley Laboratories, Llc
FDA Application #
part333D
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
10-01-2013
Listing Expiration
12-31-2019
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 54111-111-50 identifies a specific commercial package of 100 g in 1 tube of Broda Acne Spa, labeled by Bentley Laboratories, Llc. 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 Bentley Laboratories, Llc on October 01, 2013. The current certification is valid through December 31, 2019.

How is this Bentley Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54111011150. 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)
54111-111-50
11-Digit CMS (5-4-2)
54111-0111-50

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