Quality Choice Instant Ear Dry Liquid
NDC Package 63868-408-01

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

Package Information

Quality Choice Instant Ear Dry (isopropyl alcohol) liquids is apply 5 to 5 drops in each affected ear. This formulation utilizes a liquid delivery system. Marketed by Chain Drug Manufacturing Association, this product is identified by NDC 63868-408 and is authorized under FDA application M014.

Identification & Billing

NDC Package Code
63868-408-01
Package Description
30 mL in 1 CONTAINER
Product Code
63868-408
11-Digit Billing Format
63868040801
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Quality Choice Instant Ear Dry
Non-Proprietary Name
Isopropyl Alcohol
Substance Name
Isopropyl Alcohol
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s)
ISOPROPYL ALCOHOL 950 mg/mL
Usage Information
Apply 5 to 5 drops in each affected ear..

Regulatory & Marketing

Labeler Name
Chain Drug Manufacturing Association
Product Type
Human Otc Drug
FDA Application #
M014
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-28-2020
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 63868-408-01 identifies a specific commercial package of 30 ml in 1 container of Quality Choice Instant Ear Dry, a human over the counter drug labeled by Chain Drug Manufacturing Association. This product is billed per "ML" milliliter and contains an estimated amount of 30 billable units per package. This liquid is formulated for auricular (otic) use and contains isopropyl alcohol 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 Chain Drug Manufacturing Association on January 28, 2020. The current certification is valid through December 31, 2026.

How is this Chain Drug Manufacturing Association product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63868040801. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 30 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)
63868-408-01
11-Digit CMS (5-4-2)
63868-0408-01

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