Red Hot Ointment
NDC Package 82345-855-01

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

Package Information

Red Hot (capsaicin) ointment is a medication a strong counterirritant. This formulation utilizes a ointment delivery system. Marketed by The Hygenic Company, Llc, this product is identified by NDC 82345-855 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
82345-855-01
Package Description
454 g in 1 BOTTLE
Product Code
82345-855
11-Digit Billing Format
82345085501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Red Hot
Non-Proprietary Name
Capsaicin
Substance Name
Capsaicin
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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)
CAPSAICIN .5 mg/g
Usage Information
This product is a strong counterirritant. Apply sparingly. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor.

Regulatory & Marketing

Labeler Name
The Hygenic Company, Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2022
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 82345-855-01 identifies a specific commercial package of 454 g in 1 bottle of Red Hot, a human over the counter drug labeled by The Hygenic Company, Llc. This ointment is formulated for topical use and contains capsaicin 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 The Hygenic Company, Llc on April 01, 2022. The current certification is valid through December 31, 2026.

How is this The Hygenic Company, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82345085501. 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)
82345-855-01
11-Digit CMS (5-4-2)
82345-0855-01

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