Tula Skincare Breakout Star Lightweight Acne Moisturizer Cream
NDC Package 84126-229-15

11-digit billing NDC: 84126022915
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Tula Skincare Breakout Star Lightweight Acne Moisturizer (salicylic acid) cream is 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 uses daily if needed or as directed by a doctorIf bothersome dryness or peeling occurs, reduce application to once a day or every other day. This formulation utilizes a cream delivery system. Marketed by The Procter & Gamble Manufacturing Company, this product is identified by NDC 84126-229 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
84126-229-15
Package Description
15 mL in 1 TUBE
Product Code
84126-229
11-Digit Billing Format
84126022915
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tula Skincare Breakout Star Lightweight Acne Moisturizer
Non-Proprietary Name
Salicylic Acid
Substance Name
Salicylic Acid
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)
SALICYLIC ACID 2 g/100mL
Usage Information
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 uses 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
The Procter & Gamble Manufacturing Company
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2025
Listing Expiration
12-31-2027
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 (84126-229). Click a package code to view its specific billing and regulatory data.

84126-229-50
1 BOTTLE, PUMP in 1 CARTON / 50 mL in 1 BOTTLE, PUMP
84126-229-51
50 mL in 1 BOTTLE, PUMP

* 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 84126-229-15 identifies a specific commercial package of 15 ml in 1 tube of Tula Skincare Breakout Star Lightweight Acne Moisturizer, a human over the counter drug labeled by The Procter & Gamble Manufacturing Company. This cream is formulated for topical use and contains salicylic acid 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 The Procter & Gamble Manufacturing Company on June 01, 2025. The current certification is valid through December 31, 2027.

How is this The Procter & Gamble Manufacturing Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84126022915. 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)
84126-229-15
11-Digit CMS (5-4-2)
84126-0229-15

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