La Roche Posay Effaclar Dermatological Acne System 3 Step Acne Routine Kit
NDC Package 49967-282-01

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

Package Information

La Roche Posay Effaclar Dermatological Acne System 3 Step Acne Routine (benzoyl peroxide and salicylic acid) kits is use twice dailywet face, then work product into a lathermassage onto face avoiding the eyesrinse well clean the skin thoroughly before applying this productcover the entire affected area with a thin 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 cleanse the skin thoroughly before applying this productcover the entire affected area with a thin 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 dayif going outside, apply sunscreen after using this product. This formulation utilizes a kit delivery system. Marketed by L'oreal Usa Products Inc, this product is identified by NDC 49967-282 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
49967-282-01
Package Description
1 KIT in 1 CARTON * 100 mL in 1 BOTTLE * 20 mL in 1 TUBE * 100 mL in 1 TUBE
Product Code
49967-282
11-Digit Billing Format
49967028201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
La Roche Posay Effaclar Dermatological Acne System 3 Step Acne Routine
Non-Proprietary Name
Benzoyl Peroxide And Salicylic Acid
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Use twice dailywet face, then work product into a lathermassage onto face avoiding the eyesrinse well clean the skin thoroughly before applying this productcover the entire affected area with a thin 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 cleanse the skin thoroughly before applying this productcover the entire affected area with a thin 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 dayif going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Regulatory & Marketing

Labeler Name
L'oreal Usa Products Inc
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2015
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 49967-282-01 identifies a specific commercial package of 1 kit in 1 carton * 100 ml in 1 bottle * 20 ml in 1 tube * 100 ml in 1 tube of La Roche Posay Effaclar Dermatological Acne System 3 Step Acne Routine, a human over the counter drug labeled by L'oreal Usa Products Inc. This kit is formulated for use and contains 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 L'oreal Usa Products Inc on January 01, 2015. The current certification is valid through December 31, 2026.

How is this L'oreal Usa Products Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49967028201. 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)
49967-282-01
11-Digit CMS (5-4-2)
49967-0282-01

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