Earwax Removal Aid
NDC Package 49348-960-29

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

Earwax Removal Aid is  FOR USE IN THE EAR ONLYAdults and children 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 wax remaining after treatment my be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.  Children under 12 years of age, consult a doctor. Marketed by Mckesson, this product is identified by NDC 49348-960 and is authorized under FDA application part344.

Identification & Billing

NDC Package Code
49348-960-29
Package Description
15 mL in 1 BOTTLE
Product Code
49348-960
11-Digit Billing Format
49348096029
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
15 ML

Clinical Specifications

Proprietary Name
Earwax Removal Aid
Dosage Form
-
Usage Information
 FOR USE IN THE EAR ONLYAdults and children 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 wax remaining after treatment my be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.  Children under 12 years of age, consult a doctor.

Regulatory & Marketing

Labeler Name
Mckesson
FDA Application #
part344
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-24-2011
Listing Expiration
12-31-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49348-960-29 identifies a specific commercial package of 15 ml in 1 bottle of Earwax Removal Aid, labeled by Mckesson. 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 Mckesson on January 24, 2011. The current certification is valid through December 31, 2017.

How is this Mckesson product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49348096029. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 15 total billable units per package. 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)
49348-960-29
11-Digit CMS (5-4-2)
49348-0960-29

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