Salicylic Acid Liquid
NDC Package 68634-059-01

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Salicylic Acid liquids is a medication used on the skin to treat common skin and foot (plantar) warts. This formulation utilizes a liquid delivery system. Marketed by Amcol Health & Beauty Solutions, Inc. Dba, this product is identified by NDC 68634-059.

Identification & Billing

NDC Package Code
68634-059-01
Package Description
250 kg in 1 DRUM
Product Code
68634-059
11-Digit Billing Format
68634005901

Clinical Specifications

Proprietary Name
Salicylic Acid
Non-Proprietary Name
Salicylic Acid
Substance Name
Salicylic Acid
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
SALICYLIC ACID 20 g/kg
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
Amcol Health & Beauty Solutions, Inc. Dba
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
05-01-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (68634-059). Click a package code to view its specific billing and regulatory data.

68634-059-02
1 BAG in 1 BOX / 1000 kg in 1 BAG

* 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 68634-059-01 identifies a specific commercial package of 250 kg in 1 drum of Salicylic Acid (UNFINISHED drug), drug for further processing labeled by Amcol Health & Beauty Solutions, Inc. Dba. This liquid is formulated for 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 Amcol Health & Beauty Solutions, Inc. Dba on May 01, 2014. 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 Amcol Health & Beauty Solutions, Inc. Dba product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68634005901. 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)
68634-059-01
11-Digit CMS (5-4-2)
68634-0059-01

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