Acne Spot Treatment Cream
NDC Package 61328-404-05

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

Package Information

Acne Spot Treatment (salicylic acid) cream is a medication used on the skin to treat common skin and foot (plantar) warts. This formulation utilizes a cream delivery system. Marketed by Skinfix, Inc., this product is identified by NDC 61328-404 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
61328-404-05
Package Description
15 mL in 1 TUBE
Product Code
61328-404
11-Digit Billing Format
61328040405
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acne Spot Treatment 2% Bha
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
This medication is used on the skin to treat common skin and foot (plantar) warts. Salicylic acid helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Salicylic acid does not affect the virus.

Regulatory & Marketing

Labeler Name
Skinfix, Inc.
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-16-2021
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 61328-404-05 identifies a specific commercial package of 15 ml in 1 tube of Acne Spot Treatment 2% Bha, a human over the counter drug labeled by Skinfix, Inc.. 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 Skinfix, Inc. on March 16, 2021. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used on the skin to treat common skin and foot (plantar) warts. Salicylic acid helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Salicylic acid does not affect the virus.

How is this Skinfix, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61328040405. 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)
61328-404-05
11-Digit CMS (5-4-2)
61328-0404-05

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