Xesso Rear Comfort Glide Gel
NDC Package 81777-101-02

11-digit billing NDC: 81777010102
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Xesso Rear Comfort Glide (lidocaine) gel is adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly by patting or blotting with an appropriate cleansing pad. This formulation utilizes a gel delivery system. Marketed by Premium Natural Cosmetics Inc, this product is identified by NDC 81777-101 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
81777-101-02
Package Description
118 mL in 1 BOTTLE
Product Code
81777-101
11-Digit Billing Format
81777010102

Clinical Specifications

Proprietary Name
Xesso Rear Comfort Glide
Non-Proprietary Name
Lidocaine
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
Rectal - Administration to the rectum.
Active Ingredient(s)
LIDOCAINE HYDROCHLORIDE 4.625 g/100mL
Pharmacologic Class
Usage Information
Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply externally to the affected area up to 6 times daily.

Regulatory & Marketing

Labeler Name
Premium Natural Cosmetics Inc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2021
Listing Expiration
12-31-2027
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 (81777-101). Click a package code to view its specific billing and regulatory data.

81777-101-01
245 mL in 1 BOTTLE, PLASTIC
81777-101-03
473 mL in 1 BOTTLE, PUMP
81777-101-05
30 mL in 1 BOTTLE, PLASTIC

* 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 81777-101-02 identifies a specific commercial package of 118 ml in 1 bottle of Xesso Rear Comfort Glide, a human over the counter drug labeled by Premium Natural Cosmetics Inc. This gel is formulated for rectal 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 Premium Natural Cosmetics Inc on June 01, 2021. The current certification is valid through December 31, 2027.

How is this Premium Natural Cosmetics Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81777010102. 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)
81777-101-02
11-Digit CMS (5-4-2)
81777-0101-02

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