Otix Ear Wax Removal System Ear Wax And Bulb Kit
NDC Package 15579-839-33

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

Package Information

Otix Ear Wax Removal System Ear Wax And Bulb (carbamide peroxide) kits is a medication used to treat earwax buildup. This formulation utilizes a kit delivery system. Marketed by Bell Pharmaceuticals, Inc., this product is identified by NDC 15579-839 and is authorized under FDA application M014.

Identification & Billing

NDC Package Code
15579-839-33
Package Description
1 KIT in 1 KIT * 1 BOTTLE in 1 BOX (15579-838-34) / 15 mL in 1 BOTTLE
Product Code
15579-839
11-Digit Billing Format
15579083933
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Otix Ear Wax Removal System Ear Wax And Bulb
Non-Proprietary Name
Carbamide Peroxide
Dosage Form
Kit - A packaged collection of related material.
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
Human Otc Drug
FDA Application #
M014
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-01-2021
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 15579-839-33 identifies a specific commercial package of 1 kit in 1 kit * 1 bottle in 1 box (15579-838-34) / 15 ml in 1 bottle of Otix Ear Wax Removal System Ear Wax And Bulb, a human over the counter drug labeled by Bell Pharmaceuticals, Inc.. This kit is formulated for use and contains 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 October 01, 2021. 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: 15579083933. 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)
15579-839-33
11-Digit CMS (5-4-2)
15579-0839-33

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