Meijer Earwax Removal Drops Solution/ Drops
NDC Package 41250-282-34

11-digit billing NDC: 41250028234
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Meijer Earwax Removal Drops (carbamide peroxide) solution/ dropses is fOR USE IN THE EAR ONLYAdults and children over 12 years of age:Tilt head sideways and place 5 to 10 drops into earTip of applicator should not enter ear canalKeep drops in ear for several minutes by keeping head tilted or placing cotton in the earUse twice daily for up to 4 days if needed, or as directed by a doctorAny wax remaining after treatment my be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringeChildren under 12 years:consult a doctor 0. This formulation utilizes a solution/ drops delivery system. Marketed by Meijer Distribution Inc, this product is identified by NDC 41250-282 and is authorized under FDA application M014.

Identification & Billing

NDC Package Code
41250-282-34
Package Description
1 BOTTLE in 1 BOX / 15 mL in 1 BOTTLE
Product Code
41250-282
11-Digit Billing Format
41250028234
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Meijer Earwax Removal Drops
Non-Proprietary Name
Carbamide Peroxide
Substance Name
Carbamide Peroxide
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s)
CARBAMIDE PEROXIDE 65 mg/mL
Usage Information
FOR USE IN THE EAR ONLYAdults and children over 12 years of age:Tilt head sideways and place 5 to 10 drops into earTip of applicator should not enter ear canalKeep drops in ear for several minutes by keeping head tilted or placing cotton in the earUse twice daily for up to 4 days if needed, or as directed by a doctorAny wax remaining after treatment my be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringeChildren under 12 years:consult a doctor 0

Regulatory & Marketing

Labeler Name
Meijer Distribution Inc
Product Type
Human Otc Drug
FDA Application #
M014
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-27-2014
Listing Expiration
12-31-2027
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 41250-282-34 identifies a specific commercial package of 1 bottle in 1 box / 15 ml in 1 bottle of Meijer Earwax Removal Drops, a human over the counter drug labeled by Meijer Distribution Inc. This solution/ drops 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 Meijer Distribution Inc on November 27, 2014. The current certification is valid through December 31, 2027.

How is this Meijer Distribution Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41250028234. 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)
41250-282-34
11-Digit CMS (5-4-2)
41250-0282-34

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