Bubble Knock Out Acne Spot Treatment Emulsion
NDC Package 83509-002-01

11-digit billing NDC: 83509000201
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Bubble Knock Out Acne Spot Treatment (salicylic acid) emulsions is clean the skin thoroughly before applying this product. This formulation utilizes a emulsion delivery system. Marketed by Bubble Beauty, this product is identified by NDC 83509-002 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
83509-002-01
Package Description
1 TUBE in 1 CARTON / 10 mL in 1 TUBE
Product Code
83509-002
11-Digit Billing Format
83509000201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bubble Knock Out Acne Spot Treatment
Non-Proprietary Name
Salicylic Acid
Substance Name
Salicylic Acid
Dosage Form
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
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 18 mg/mL
Usage Information
Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer 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
Bubble Beauty
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83509-002-01 identifies a specific commercial package of 1 tube in 1 carton / 10 ml in 1 tube of Bubble Knock Out Acne Spot Treatment, a human over the counter drug labeled by Bubble Beauty. This emulsion 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 Bubble Beauty on April 01, 2023. The current certification is valid through December 31, 2027.

How is this Bubble Beauty product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83509000201. 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)
83509-002-01
11-Digit CMS (5-4-2)
83509-0002-01

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