Earclearrx
NDC Package 74318-102-05

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.

Earclearrx is fOR USE IN THE EAR ONLY. Marketed by Nuance Medical, Llc, this product is identified by NDC 74318-102 and is authorized under FDA application part344.

Identification & Billing

NDC Package Code
74318-102-05
Package Description
15 mL in 1 BOTTLE, DROPPER
Product Code
74318-102
11-Digit Billing Format
74318010205
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Earclearrx
Dosage Form
-
Usage Information
FOR USE IN THE EAR ONLY. Tilt head sideways, place 5-10 drops in the ear, tip of the applicator should not enter the ear canal. Keep drops in the ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to four days if needed or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using an ear irrigation system.

Regulatory & Marketing

Labeler Name
Nuance Medical, Llc
FDA Application #
part344
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-01-2022
Listing Expiration
12-31-2023
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 74318-102-05 identifies a specific commercial package of 15 ml in 1 bottle, dropper of Earclearrx, labeled by Nuance Medical, Llc. 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 Nuance Medical, Llc on January 01, 2022. The current certification is valid through December 31, 2023.

How is this Nuance Medical, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 74318010205. 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)
74318-102-05
11-Digit CMS (5-4-2)
74318-0102-05

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