Tinactin Aerosol, Spray
NDC Package 11523-0165-3

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

Package Information

Tinactin (tolnaftate) aerosols is tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. This formulation utilizes a aerosol, spray delivery system. Marketed by Bayer Healthcare Llc, this product is identified by NDC 11523-0165 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
11523-0165-3
Package Description
150 g in 1 CAN
Product Code
11523-0165
11-Digit Billing Format
11523016503
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
150 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tinactin
Non-Proprietary Name
Tolnaftate
Substance Name
Tolnaftate
Dosage Form
Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous 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)
TOLNAFTATE 10 mg/g
Usage Information
Tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. It is an antifungal that works by preventing the growth of fungus.

Regulatory & Marketing

Labeler Name
Bayer Healthcare Llc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-23-1993
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 11523-0165-3 identifies a specific commercial package of 150 g in 1 can of Tinactin, a human over the counter drug labeled by Bayer Healthcare Llc. This aerosol, spray is formulated for topical use and contains tolnaftate 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 Bayer Healthcare Llc on September 23, 1993. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. It is an antifungal that works by preventing the growth of fungus.

How is this Bayer Healthcare Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11523016503. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 150 total billable units per package. 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 (5-4-1)
11523-0165-3
11-Digit CMS (5-4-2)
11523-0165-03

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