Carbamide Peroxide Solution/ Drops
NDC Package 15579-840-36

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

Carbamide Peroxide solution/ dropses is a medication used to treat earwax buildup. This formulation utilizes a solution/ drops delivery system. Marketed by Bell Pharmaceuticals, Inc., this product is identified by NDC 15579-840.

Identification & Billing

NDC Package Code
15579-840-36
Package Description
15 mL in 1 BOTTLE
Product Code
15579-840
11-Digit Billing Format
15579084036

Clinical Specifications

Proprietary Name
Carbamide Peroxide
Non-Proprietary Name
Carbamide Peroxide
Substance Name
Carbamide Peroxide
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Active Ingredient(s)
CARBAMIDE PEROXIDE 65 mg/mL
Usage Information
This medication is used to treat earwax buildup. It helps to soften, loosen, and remove the earwax. Too much earwax can block the ear canal and reduce hearing. This medication releases oxygen and starts to foam when it comes in contact with the skin. The foaming helps break up and remove the earwax. Consult your doctor before using this product in children younger than 12 years.

Regulatory & Marketing

Labeler Name
Bell Pharmaceuticals, Inc.
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
03-01-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 15579-840-36 identifies a specific commercial package of 15 ml in 1 bottle of Carbamide Peroxide (UNFINISHED drug), drug for further processing labeled by Bell Pharmaceuticals, Inc.. This solution/ drops is formulated for use and contains carbamide peroxide 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 Bell Pharmaceuticals, Inc. on March 01, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat earwax buildup. It helps to soften, loosen, and remove the earwax. Too much earwax can block the ear canal and reduce hearing. This medication releases oxygen and starts to foam when it comes in contact with the skin. The foaming helps break up and remove the earwax. Consult your doctor before using this product in children younger than 12 years.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 15579084036. 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)
15579-840-36
11-Digit CMS (5-4-2)
15579-0840-36

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