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  5. NDC Package Code: 25047-755-01 Kolorz Topical Anesthetic Pina Colada

NDC Package 25047-755-01 Kolorz Topical Anesthetic Pina Colada

Benzocaine Gel Dental - 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:
25047-755-01
Package Description:
29.6 g in 1 BOTTLE
Product Code:
25047-755
Proprietary Name:
Kolorz Topical Anesthetic Pina Colada
Non-Proprietary Name:
Benzocaine
Substance Name:
Benzocaine
Usage Information:
Adults and children 2 years of age and older: apply only amount needed to the oral mucosa to prevent or relieve painchildren under 2 years of age: do not use
11-Digit NDC Billing Format:
25047075501
NDC to RxNorm Crosswalk:
  • RxCUI: 238910 - benzocaine 20 % Oral Gel
  • RxCUI: 238910 - benzocaine 0.2 MG/MG Oral Gel
  • RxCUI: 238910 - benzocaine 20 % (180-220 MG per 1 GM) Oral Gel
  • RxCUI: 856886 - Kolorz Anesthetic 20 % Oral Gel
  • RxCUI: 856886 - benzocaine 0.2 MG/MG Oral Gel [Kolorz Anesthetic]
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Dmg America, Llc
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • BENZOCAINE 200 mg/g
    • Pharmacologic Class(es):
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    part356
    Marketing Category:
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date:
    09-06-2019
    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 25047-755-01?

    The NDC Packaged Code 25047-755-01 is assigned to a package of 29.6 g in 1 bottle of Kolorz Topical Anesthetic Pina Colada, a human over the counter drug labeled by Dmg America, Llc. The product's dosage form is gel and is administered via dental form.

    Is NDC 25047-755 included in the NDC Directory?

    Yes, Kolorz Topical Anesthetic Pina Colada with product code 25047-755 is active and included in the NDC Directory. The product was first marketed by Dmg America, Llc on September 06, 2019 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 25047-755-01?

    The 11-digit format is 25047075501. 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
    5-3-225047-755-015-4-225047-0755-01