Black Label Spray
NDC Package 82617-103-59

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

Package Information

Black Label (lidocaine hydrochloride) sprays is aDULTS AND CHILDREN 12 YEARS AND OVERCLEANSE THE AFFECTED AREA WITH MILD SOAP AND WARM WATERRINSE WELL OR PAT WITH AN APPROPRIATE CLEANSING PADGENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLYING THIS PRODUCTUSE SPRAY PUMP TO APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 4 TIMES DAILYDO NOT USE MORE OFTEN THAN DIRECTED. This formulation utilizes a spray delivery system. Marketed by Scalp Tech Inc, this product is identified by NDC 82617-103 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
82617-103-59
Package Description
59 mL in 1 BOTTLE, SPRAY
Product Code
82617-103
11-Digit Billing Format
82617010359
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Black Label B Numb
Non-Proprietary Name
Lidocaine Hydrochloride
Substance Name
Lidocaine Hydrochloride
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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 5 g/100mL
Pharmacologic Class
Usage Information
ADULTS AND CHILDREN 12 YEARS AND OVERCLEANSE THE AFFECTED AREA WITH MILD SOAP AND WARM WATERRINSE WELL OR PAT WITH AN APPROPRIATE CLEANSING PADGENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLYING THIS PRODUCTUSE SPRAY PUMP TO APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 4 TIMES DAILYDO NOT USE MORE OFTEN THAN DIRECTED

Regulatory & Marketing

Labeler Name
Scalp Tech Inc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-23-2023
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 82617-103-59 identifies a specific commercial package of 59 ml in 1 bottle, spray of Black Label B Numb, a human over the counter drug labeled by Scalp Tech Inc. This spray 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 Scalp Tech Inc on February 23, 2023. The current certification is valid through December 31, 2027.

How is this Scalp Tech Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82617010359. 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)
82617-103-59
11-Digit CMS (5-4-2)
82617-0103-59

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