Wax Out Plus Solution/ Drops
NDC Package 13709-313-01

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

Package Information

Wax Out Plus (carbamide peroxide drops) solution/ dropses is a medication used to treat earwax buildup. This formulation utilizes a solution/ drops delivery system. Marketed by Neilmed Pharmaceuticals Inc, this product is identified by NDC 13709-313 and is authorized under FDA application M014.

Identification & Billing

NDC Package Code
13709-313-01
Package Description
1 BOTTLE, DROPPER in 1 KIT / 15 mL in 1 BOTTLE, DROPPER
Product Code
13709-313
11-Digit Billing Format
13709031301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Wax Out Plus
Non-Proprietary Name
Carbamide Peroxide Drops
Substance Name
Carbamide Peroxide
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Auricular (otic) - Administration to or by way of the ear.
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
Neilmed Pharmaceuticals Inc
Product Type
Human Otc Drug
FDA Application #
M014
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-05-2018
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 13709-313-01 identifies a specific commercial package of 1 bottle, dropper in 1 kit / 15 ml in 1 bottle, dropper of Wax Out Plus, a human over the counter drug labeled by Neilmed Pharmaceuticals Inc. This solution/ drops is formulated for auricular (otic) 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 Neilmed Pharmaceuticals Inc on November 05, 2018. 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 Neilmed Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13709031301. 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)
13709-313-01
11-Digit CMS (5-4-2)
13709-0313-01

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