Lidocaine Hydrochloride Gel
NDC Package 61010-5000-3

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

Package Information

Lidocaine Hydrochloride gel is for adults and children 2 years and older: apply to affected area not more than 4 times daily children under 2: do not use, consult a doctor. This formulation utilizes a gel delivery system. Marketed by Safetec Of America, Inc., this product is identified by NDC 61010-5000 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
61010-5000-3
Package Description
.9 g in 1 POUCH
Product Code
61010-5000
11-Digit Billing Format
61010500003
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lidocaine Hydrochloride
Non-Proprietary Name
Lidocaine Hydrochloride
Substance Name
Lidocaine 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)
LIDOCAINE HYDROCHLORIDE 20 mg/g
Pharmacologic Class
Usage Information
For adults and children 2 years and older: apply to affected area not more than 4 times daily children under 2: do not use, consult a doctor

Regulatory & Marketing

Labeler Name
Safetec Of America, Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-19-2012
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61010-5000). Click a package code to view its specific billing and regulatory data.

61010-5000-0
3.3 g in 1 PACKET
61010-5000-1
121.2 g in 1 BOTTLE
61010-5000-4
144 POUCH in 1 CARTON / .9 g in 1 POUCH
61010-5000-5
25 POUCH in 1 CARTON / .9 g in 1 POUCH
61010-5000-6
10 PACKET in 1 BOX / .9 g in 1 PACKET

* 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 61010-5000-3 identifies a specific commercial package of .9 g in 1 pouch of Lidocaine Hydrochloride, a human over the counter drug labeled by Safetec Of America, Inc.. This gel is formulated for topical use and contains lidocaine 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 Safetec Of America, Inc. on September 19, 2012. The current certification is valid through December 31, 2026.

How is this Safetec Of America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61010500003. 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 (5-4-1)
61010-5000-3
11-Digit CMS (5-4-2)
61010-5000-03

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