Calexotics Sta-hard Cream
NDC Package 88055-011-11

11-digit billing NDC: 88055001111
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Calexotics Sta-hard Cream (desensitizer maximum strength) cream is apply a small amount to the head and shaft of the penis before intercourse or use as directed by a doctor. This formulation utilizes a cream delivery system. Marketed by California Exotic Novelties, Llc, this product is identified by NDC 88055-011 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
88055-011-11
Package Description
118 mL in 1 TUBE
Product Code
88055-011
11-Digit Billing Format
88055001111

Clinical Specifications

Proprietary Name
Calexotics Sta-hard Cream
Non-Proprietary Name
Desensitizer Maximum Strength
Substance Name
Benzocaine
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
BENZOCAINE 7.5 mg/100mL
Pharmacologic Class
Usage Information
Apply a small amount to the head and shaft of the penis before intercourse or use as directed by a doctor. Wash product off after intercourse. Children under 2 years of age: Do not use.

Regulatory & Marketing

Labeler Name
California Exotic Novelties, Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-31-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 88055-011-11 identifies a specific commercial package of 118 ml in 1 tube of Calexotics Sta-hard Cream, a human over the counter drug labeled by California Exotic Novelties, Llc. This cream is formulated for topical use and contains benzocaine 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 California Exotic Novelties, Llc on May 31, 2023. The current certification is valid through December 31, 2027.

How is this California Exotic Novelties, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 88055001111. 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)
88055-011-11
11-Digit CMS (5-4-2)
88055-0011-11

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