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  5. NDC Package Code: 69805-400-01 Zensa Numbing Gel

NDC Package 69805-400-01 Zensa Numbing Gel

Lidocaine 5%,Phenylephrine Hydrochloride 0.25% Gel Rectal - 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:
69805-400-01
Package Description:
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code:
69805-400
Proprietary Name:
Zensa Numbing Gel
Non-Proprietary Name:
Lidocaine 5%, Phenylephrine Hydrochloride 0.25%
Substance Name:
Lidocaine; Phenylephrine Hydrochloride
Usage Information:
Children under 12 years of age: Consult a doctor.Apply externally to the affected area up to 4 times daily.
11-Digit NDC Billing Format:
69805040001
NDC to RxNorm Crosswalk:
  • RxCUI: 2621576 - lidocaine 5 % / phenylephrine HCl 0.25 % Rectal Gel
  • RxCUI: 2621576 - lidocaine 0.05 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Gel
  • RxCUI: 2621576 - lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal Gel
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Alera Skin Care Products Inc.
    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):
  • Rectal - Administration to the rectum.
    • Active Ingredient(s):
  • LIDOCAINE 5 g/100g
  • PHENYLEPHRINE HYDROCHLORIDE .25 g/100g
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Amide Local Anesthetic - [EPC] (Established Pharmacologic Class)
  • Amides - [CS]
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Local Anesthesia - [PE] (Physiologic Effect)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M015
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    09-25-2023
    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 69805-400-01?

    The NDC Packaged Code 69805-400-01 is assigned to a package of 1 tube in 1 carton / 30 g in 1 tube of Zensa Numbing Gel, a human over the counter drug labeled by Alera Skin Care Products Inc.. The product's dosage form is gel and is administered via rectal form.

    Is NDC 69805-400 included in the NDC Directory?

    Yes, Zensa Numbing Gel with product code 69805-400 is active and included in the NDC Directory. The product was first marketed by Alera Skin Care Products Inc. on September 25, 2023 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 69805-400-01?

    The 11-digit format is 69805040001. 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
    5-3-269805-400-015-4-269805-0400-01