Ear Drops Liquid
NDC Package 0904-6627-35

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Ear Drops (carbamide peroxide 6.5%) liquids is a medication used to treat earwax buildup. This formulation utilizes a liquid delivery system. Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-6627 and is authorized under FDA application M014.

Identification & Billing

NDC Package Code
0904-6627-35
Package Description
1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE
Product Code
0904-6627
11-Digit Billing Format
00904662735
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ear Drops Major
Non-Proprietary Name
Carbamide Peroxide 6.5%
Substance Name
Carbamide Peroxide
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)
CARBAMIDE PEROXIDE 6.5 g/100mL
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
Major Pharmaceuticals
Product Type
Human Otc Drug
FDA Application #
M014
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-10-2019
End Marketing Date
09-30-2026
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 0904-6627-35 identifies a specific commercial package of 1 bottle in 1 carton / 15 ml in 1 bottle of Ear Drops Major, a human over the counter drug labeled by Major Pharmaceuticals. This liquid 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 Major Pharmaceuticals on October 10, 2019.

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 Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904662735. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0904-6627-35
11-Digit CMS (5-4-2)
00904-6627-35

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