Comfortcaine Gel
NDC Package 65008-005-04

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

Package Information

Comfortcaine (lidocaine hcl) gel is a medication used to prevent and relieve pain during certain medical procedures (such as inserting a tube into the urinary tract). This formulation utilizes a gel delivery system. Marketed by Qs Key West Aloe, Llc, this product is identified by NDC 65008-005 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
65008-005-04
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 113 g in 1 BOTTLE, PLASTIC
Product Code
65008-005
11-Digit Billing Format
65008000504
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Comfortcaine
Non-Proprietary Name
Lidocaine Hcl
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 40 mg/g
Pharmacologic Class
Usage Information
This medication is used to prevent and relieve pain during certain medical procedures (such as inserting a tube into the urinary tract). It is also used to numb the lining of the mouth, throat, or nose before certain medical procedures (such as intubation). Lidocaine jelly is also used to relieve pain caused by swelling of the urinary tract (urethritis). It works by numbing certain areas of the body that are moist. Lidocaine belongs to a class of drugs known as local anesthetics.

Regulatory & Marketing

Labeler Name
Qs Key West Aloe, Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-12-2004
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 65008-005-04 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 113 g in 1 bottle, plastic of Comfortcaine, a human over the counter drug labeled by Qs Key West Aloe, Llc. 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 Qs Key West Aloe, Llc on November 12, 2004. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent and relieve pain during certain medical procedures (such as inserting a tube into the urinary tract). It is also used to numb the lining of the mouth, throat, or nose before certain medical procedures (such as intubation). Lidocaine jelly is also used to relieve pain caused by swelling of the urinary tract (urethritis). It works by numbing certain areas of the body that are moist. Lidocaine belongs to a class of drugs known as local anesthetics.

How is this Qs Key West Aloe, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65008000504. 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)
65008-005-04
11-Digit CMS (5-4-2)
65008-0005-04

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