Skins Delay Maximum Strength Lidocaine Solution
NDC Package 81923-199-00

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

Package Information

Skins Delay Maximum Strength Lidocaine (lidocaine hydrochloride) solution is apply 3 or more sprays to the head and shaft of the penis depending on the level of anaesthesia desired. This formulation utilizes a solution delivery system. Marketed by Skins Sexual Health Limited, this product is identified by NDC 81923-199 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
81923-199-00
Package Description
1 CYLINDER in 1 BOX / 15 mL in 1 CYLINDER
Product Code
81923-199
11-Digit Billing Format
81923019900

Clinical Specifications

Proprietary Name
Skins Delay Maximum Strength Lidocaine
Non-Proprietary Name
Lidocaine Hydrochloride
Substance Name
Lidocaine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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 10 mg/mL
Pharmacologic Class
Usage Information
Apply 3 or more sprays to the head and shaft of the penis depending on the level of anaesthesia desired. Do not exceed 10 sprays. Massage into the penis for around twenty seconds or until optimal absorption is reached. Wash hands thoroughly after use. You will feel the product start to work after 3-5 minutes so although you can apply up to 10 sprays we recommend waiting to feel the full effects before applying any more. You should always use minimum effective quantity.

Regulatory & Marketing

Labeler Name
Skins Sexual Health Limited
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-25-2021
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 81923-199-00 identifies a specific commercial package of 1 cylinder in 1 box / 15 ml in 1 cylinder of Skins Delay Maximum Strength Lidocaine, a human over the counter drug labeled by Skins Sexual Health Limited. This solution 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 Skins Sexual Health Limited on May 25, 2021. The current certification is valid through December 31, 2026.

How is this Skins Sexual Health Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81923019900. 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)
81923-199-00
11-Digit CMS (5-4-2)
81923-0199-00

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