Zensa Numbing Gel
NDC Package 69805-400-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Zensa Numbing Gel (lidocaine 5%, phenylephrine hydrochloride 0.25%) gel is children under 12 years of age: Consult a doctor.Apply externally to the affected area up to 4 times daily. This formulation utilizes a gel delivery system. Marketed by Alera Skin Care Products Inc., this product is identified by NDC 69805-400 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
69805-400-01
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
69805-400
11-Digit Billing Format
69805040001
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

Clinical Specifications

Proprietary Name
Zensa Numbing Gel
Non-Proprietary Name
Lidocaine 5%, Phenylephrine Hydrochloride 0.25%
Substance Name
Lidocaine; Phenylephrine Hydrochloride
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
Rectal - Administration to the rectum.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Children under 12 years of age: Consult a doctor.Apply externally to the affected area up to 4 times daily.

Regulatory & Marketing

Labeler Name
Alera Skin Care Products Inc.
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-25-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69805-400-01 identifies a specific commercial 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.. This gel is formulated for rectal use and contains lidocaine; phenylephrine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Alera Skin Care Products Inc. on September 25, 2023. The current certification is valid through December 31, 2026.

How is this Alera Skin Care Products Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69805040001. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
69805-400-01
11-Digit CMS (5-4-2)
69805-0400-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.