1. Home
  2. Labeler Index
  3. Bell Pharmaceuticals, Inc.
  4. 15579-838
  5. NDC Package Code: 15579-838-34 Otix Ear Wax Removal Drops

NDC Package 15579-838-34 Otix Ear Wax Removal Drops

Carbamide Peroxide Solution/ Drops Auricular (otic) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
15579-838-34
Package Description:
1 BOTTLE in 1 BOX / 15 mL in 1 BOTTLE
Product Code:
15579-838
Proprietary Name:
Otix Ear Wax Removal Drops
Non-Proprietary Name:
Carbamide Peroxide
Substance Name:
Carbamide Peroxide
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.
11-Digit NDC Billing Format:
15579083834
NDC to RxNorm Crosswalk:
  • RxCUI: 2588948 - Otix 6.5 % Otic Solution
  • RxCUI: 2588948 - carbamide peroxide 65 MG/ML Otic Solution [Otix]
  • RxCUI: 2588948 - Otix 65 MG/ML Otic Solution
  • RxCUI: 702050 - carbamide peroxide 6.5 % Otic Solution
  • RxCUI: 702050 - carbamide peroxide 65 MG/ML Otic Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Bell Pharmaceuticals, Inc.
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    Administration Route(s):
  • Auricular (otic) - Administration to or by way of the ear.
    • Active Ingredient(s):
  • CARBAMIDE PEROXIDE 65 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    M014
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    10-01-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 15579-838-34?

    The NDC Packaged Code 15579-838-34 is assigned to a package of 1 bottle in 1 box / 15 ml in 1 bottle of Otix Ear Wax Removal Drops, a human over the counter drug labeled by Bell Pharmaceuticals, Inc.. The product's dosage form is solution/ drops and is administered via auricular (otic) form.

    Is NDC 15579-838 included in the NDC Directory?

    Yes, Otix Ear Wax Removal Drops with product code 15579-838 is active and included in the NDC Directory. The product was first marketed by Bell Pharmaceuticals, Inc. on October 01, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 15579-838-34?

    The 11-digit format is 15579083834. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-215579-838-345-4-215579-0838-34