Ear Wax Removal Drops
NDC Package 50804-341-51

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ear Wax Removal Drops is Adults and children over 12 years of age:  Tilt head sideways and place 5 to 10 drops into ear.Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Marketed by Goodsense, this product is identified by NDC 50804-341 and is authorized under FDA application part344.

Identification & Billing

NDC Package Code
50804-341-51
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER
Product Code
50804-341
11-Digit Billing Format
50804034151
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ear Wax Removal Drops
Dosage Form
-
Usage Information
Adults and children over 12 years of age:  Tilt head sideways and place 5 to 10 drops into ear.Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor.  Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.Children under 12 years:  consult a doctor.

Regulatory & Marketing

Labeler Name
Goodsense
FDA Application #
part344
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
06-05-2019
Listing Expiration
12-31-2022
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50804-341). Click a package code to view its specific billing and regulatory data.

50804-341-61
1 BOTTLE, DROPPER in 1 KIT / 15 mL in 1 BOTTLE, DROPPER

* 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 50804-341-51 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper of Ear Wax Removal Drops, labeled by Goodsense. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Goodsense on June 05, 2019. The current certification is valid through December 31, 2022.

How is this Goodsense product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50804034151. 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)
50804-341-51
11-Digit CMS (5-4-2)
50804-0341-51

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