Dermasolve Medicated Lotion/shampoo
NDC Package 84285-101-08

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

Package Information

Dermasolve Medicated (salicylic acid) lotion/shampoos is a medication used on the skin to treat common skin and foot (plantar) warts. This formulation utilizes a lotion/shampoo delivery system. Marketed by Fortitude Health, Llc, this product is identified by NDC 84285-101 and is authorized under FDA application M032.

Identification & Billing

NDC Package Code
84285-101-08
Package Description
226 g in 1 BOTTLE
Product Code
84285-101
11-Digit Billing Format
84285010108
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dermasolve Medicated
Non-Proprietary Name
Salicylic Acid
Substance Name
Salicylic Acid
Dosage Form
Lotion/shampoo - A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it is often used as a vehicle for dermatologic agents.
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 3 g/100g
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
Fortitude Health, Llc
Product Type
Human Otc Drug
FDA Application #
M032
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-21-2024
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 84285-101-08 identifies a specific commercial package of 226 g in 1 bottle of Dermasolve Medicated, a human over the counter drug labeled by Fortitude Health, Llc. This lotion/shampoo 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 Fortitude Health, Llc on October 21, 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 Fortitude Health, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84285010108. 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)
84285-101-08
11-Digit CMS (5-4-2)
84285-0101-08

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