Pro Clear Serum
NDC Package 79061-040-01

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.

Pro Clear Serum is sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. Marketed by Relumins Labs Llc, this product is identified by NDC 79061-040 and is authorized under FDA application part333D.

Identification & Billing

NDC Package Code
79061-040-01
Package Description
1 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE
Product Code
79061-040
11-Digit Billing Format
79061004001

Clinical Specifications

Proprietary Name
Pro Clear Serum
Dosage Form
-
Usage Information
Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated belowclean the skin thoroughly before applying this productcover the entire affected area with a layer one to three times dailybecause 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 doctorif bothersome dryness or peeling occurs, reduce application to once a day or every other day

Regulatory & Marketing

Labeler Name
Relumins Labs 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
07-31-2018
Listing Expiration
12-31-2022
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 79061-040-01 identifies a specific commercial package of 1 bottle in 1 carton / 50 ml in 1 bottle of Pro Clear Serum, labeled by Relumins Labs 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 Relumins Labs Llc on July 31, 2018. The current certification is valid through December 31, 2022.

How is this Relumins Labs Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79061004001. 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)
79061-040-01
11-Digit CMS (5-4-2)
79061-0040-01

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