Secondary Numb Lidocaine Phenylephrine Gel
NDC Package 83120-378-00

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

Package Information

Secondary Numb Lidocaine Phenylephrine Gel (lidocaine, phenylephrine hydrochloride) gel is adults and children 12 years and over: • Children under 12 consult a doctor • Cleanse the affected area with mild soap and warm water. This formulation utilizes a gel delivery system. Marketed by Lalani Rx Consulting, Inc., this product is identified by NDC 83120-378 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
83120-378-00
Package Description
1 TUBE in 1 BOX / 31.18 g in 1 TUBE
Product Code
83120-378
11-Digit Billing Format
83120037800
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
Secondary Numb Lidocaine Phenylephrine Gel
Non-Proprietary Name
Lidocaine, Phenylephrine Hydrochloride
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
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)
Pharmacologic Class
Usage Information
Adults and children 12 years and over: • Children under 12 consult a doctor • Cleanse the affected area with mild soap and warm water. Rinse well or pat with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying this product • Apply to the affected area up to 3 times daily • Do not use more often than directed

Regulatory & Marketing

Labeler Name
Lalani Rx Consulting, Inc.
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-10-2022
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 83120-378-00 identifies a specific commercial package of 1 tube in 1 box / 31.18 g in 1 tube of Secondary Numb Lidocaine Phenylephrine Gel, a human over the counter drug labeled by Lalani Rx Consulting, Inc.. This gel is formulated for topical 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 Lalani Rx Consulting, Inc. on October 10, 2022. The current certification is valid through December 31, 2026.

How is this Lalani Rx Consulting, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83120037800. 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)
83120-378-00
11-Digit CMS (5-4-2)
83120-0378-00

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