NDC Package 13709-314-01 Neilmed Clear Canal Earwax Removal Kit

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

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:
13709-314-01
Package Description:
1 BOTTLE, DROPPER in 1 KIT / 15 mL in 1 BOTTLE, DROPPER
Product Code:
Proprietary Name:
Neilmed Clear Canal Earwax Removal Kit
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:
13709031401
NDC to RxNorm Crosswalk:
  • RxCUI: 702050 - carbamide peroxide 6.5 % Otic Solution
  • RxCUI: 702050 - carbamide peroxide 65 MG/ML Otic Solution
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Neilmed 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):
    Sample Package:
    No
    FDA Application Number:
    M014
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    12-25-2021
    Listing Expiration Date:
    12-31-2025
    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 13709-314-01?

    The NDC Packaged Code 13709-314-01 is assigned to a package of 1 bottle, dropper in 1 kit / 15 ml in 1 bottle, dropper of Neilmed Clear Canal Earwax Removal Kit, a human over the counter drug labeled by Neilmed Pharmaceuticals Inc. The product's dosage form is solution/ drops and is administered via auricular (otic) form.

    Is NDC 13709-314 included in the NDC Directory?

    Yes, Neilmed Clear Canal Earwax Removal Kit with product code 13709-314 is active and included in the NDC Directory. The product was first marketed by Neilmed Pharmaceuticals Inc on December 25, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 13709-314-01?

    The 11-digit format is 13709031401. 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
    5-3-213709-314-015-4-213709-0314-01