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  5. NDC Package Code: 54723-998-01 Comfortox Lidocaine

NDC Package 54723-998-01 Comfortox Lidocaine

Lidocaine Hydrochloride Cream 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:
54723-998-01
Package Description:
2000 mg in 1 PACKET
Product Code:
54723-998
Proprietary Name:
Comfortox Lidocaine
Non-Proprietary Name:
Lidocaine Hydrochloride
Substance Name:
Lidocaine Hydrochloride
Usage Information:
For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily.  Children under 2 years of age: consult a physician.  Apply in a circular motion for 50 to 60 seconds.
11-Digit NDC Billing Format:
54723099801
NDC to RxNorm Crosswalk:
  • RxCUI: 1010895 - lidocaine HCl 4 % Topical Cream
  • RxCUI: 1010895 - lidocaine hydrochloride 40 MG/ML Topical Cream
  • RxCUI: 1010895 - lidocaine hydrochloride 4 % Topical Cream
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Sambria Pharmaceuticals
    Dosage Form:
    Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
    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):
  • LIDOCAINE HYDROCHLORIDE 40 mg/1000mg
    • Pharmacologic Class(es):
  • Amide Local Anesthetic - [EPC] (Established Pharmacologic Class)
  • Amides - [CS]
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Local Anesthesia - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    M017
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    09-14-2016
    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 54723-998-01?

    The NDC Packaged Code 54723-998-01 is assigned to a package of 2000 mg in 1 packet of Comfortox Lidocaine, a human over the counter drug labeled by Sambria Pharmaceuticals. The product's dosage form is cream and is administered via topical form.

    Is NDC 54723-998 included in the NDC Directory?

    Yes, Comfortox Lidocaine with product code 54723-998 is active and included in the NDC Directory. The product was first marketed by Sambria Pharmaceuticals on September 14, 2016 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 54723-998-01?

    The 11-digit format is 54723099801. 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
    5-3-254723-998-015-4-254723-0998-01