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  5. NDC Package Code: 63102-107-01 Actisep

NDC Package 63102-107-01 Actisep

Benzocaine,Menthol,Cetylpyridinium Chloride Spray Topical - 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:
63102-107-01
Package Description:
30 mL in 1 BOTTLE, SPRAY
Product Code:
63102-107
Proprietary Name:
Actisep
Non-Proprietary Name:
Benzocaine, Menthol, Cetylpyridinium Chloride
Substance Name:
Benzocaine; Cetylpyridinium Chloride; Menthol, Unspecified Form
Usage Information:
Adults and Children 6 years and over:Spray Actisep several times to affected area in mouth or lips. Do not use more than 4 times a day.Children under 12 years of age should be supervised in the use of this product. -Children under 6 years of age:Consult a physician.For sore gums associated with teething, spray a small amount on finger and rub on gums after you wash your hands. -As a gargle or mouthwash, Adults and Children 12 years and over, place ½ teaspoon (2.5 mL) in ½ glass of warm water several times a day. Do not use more than 4 times a day. -
11-Digit NDC Billing Format:
63102010701
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
30 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1426687 - benzocaine 2 % / cetylpyridinium chloride 0.1 % / menthol 0.5 % Mucosal Spray
  • RxCUI: 1426687 - benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 5 MG/ML Mucosal Spray
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Actipharma, Inc
    Dosage Form:
    Spray - A liquid minutely divided as by a jet of air or steam.
    Administration Route(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • BENZOCAINE 2 g/100mL
  • CETYLPYRIDINIUM CHLORIDE .1 g/100mL
  • MENTHOL, UNSPECIFIED FORM .5 g/100mL
    • 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:
    12-28-2015
    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 63102-107-01?

    The NDC Packaged Code 63102-107-01 is assigned to a package of 30 ml in 1 bottle, spray of Actisep, a human over the counter drug labeled by Actipharma, Inc. The product's dosage form is spray and is administered via topical form.This product is billed per "ML" milliliter and contains an estimated amount of 30 billable units per package.

    Is NDC 63102-107 included in the NDC Directory?

    Yes, Actisep with product code 63102-107 is active and included in the NDC Directory. The product was first marketed by Actipharma, Inc on December 28, 2015 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 NDC billing unit for package 63102-107-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 63102-107-01?

    The 11-digit format is 63102010701. 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
    5-3-263102-107-015-4-263102-0107-01