B Pure Pressed Powder For Acne Prone Skin Fair Powder
NDC Package 80684-110-00

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

Package Information

B Pure Pressed Powder For Acne Prone Skin Fair (salicylic acid) powders is a medication used on the skin to treat common skin and foot (plantar) warts. This formulation utilizes a powder delivery system. Marketed by Fourstar Group Usa, Inc., this product is identified by NDC 80684-110 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
80684-110-00
Package Description
4.8 g in 1 CONTAINER
Product Code
80684-110
11-Digit Billing Format
80684011000
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
B Pure Pressed Powder For Acne Prone Skin Fair
Non-Proprietary Name
Salicylic Acid
Substance Name
Salicylic Acid
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
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 5 mg/g
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
Fourstar Group Usa, Inc.
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-01-2024
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 80684-110-00 identifies a specific commercial package of 4.8 g in 1 container of B Pure Pressed Powder For Acne Prone Skin Fair, a human over the counter drug labeled by Fourstar Group Usa, Inc.. This powder 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 Fourstar Group Usa, Inc. on September 01, 2024. The current certification is valid through December 31, 2026.

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 Fourstar Group Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80684011000. 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)
80684-110-00
11-Digit CMS (5-4-2)
80684-0110-00

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