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  5. NDC Package Code: 85424-007-01 Roycederm Cooldefense Refreshing Shower Gel

NDC Package 85424-007-01 Roycederm Cooldefense Refreshing Shower Gel

Tolnaftate 1.0% Liquid Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
85424-007-01
Package Description:
2 BOTTLE, PUMP in 1 CARTON / 250 mL in 1 BOTTLE, PUMP
Product Code:
85424-007
Proprietary Name:
Roycederm Cooldefense Refreshing Shower Gel
Non-Proprietary Name:
Tolnaftate 1.0%
Substance Name:
Tolnaftate
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.
11-Digit NDC Billing Format:
85424000701
Product Type:
Human Otc Drug
Labeler Name:
Roycederm Llc
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s):
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 1 g/100mL
Sample Package:
No
FDA Application Number:
M005
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
08-31-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 85424-007-01?

The NDC Packaged Code 85424-007-01 is assigned to a package of 2 bottle, pump in 1 carton / 250 ml in 1 bottle, pump of Roycederm Cooldefense Refreshing Shower Gel, a human over the counter drug labeled by Roycederm Llc. The product's dosage form is liquid and is administered via topical form.

Is NDC 85424-007 included in the NDC Directory?

Yes, Roycederm Cooldefense Refreshing Shower Gel with product code 85424-007 is active and included in the NDC Directory. The product was first marketed by Roycederm Llc on August 31, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 85424-007-01?

The 11-digit format is 85424000701. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-285424-007-015-4-285424-0007-01