Dandrx Anti-dandruff Shampoo
NDC Package 85521-002-08

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

Package Information

Dandrx Anti-dandruff (zinc pyrithione) shampoos is • Wet hair, massage shampoo into scalp, rinse thoroughly, and repeat if desired.• For best results, use at least twice a week or as directed by a doctor.• For maximum dandruff control, use every time you shampoo. This formulation utilizes a shampoo delivery system. Marketed by Dandrx Llc, this product is identified by NDC 85521-002 and is authorized under FDA application M032.

Identification & Billing

NDC Package Code
85521-002-08
Package Description
237 mL in 1 BOTTLE
Product Code
85521-002
11-Digit Billing Format
85521000208
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dandrx Anti-dandruff
Non-Proprietary Name
Zinc Pyrithione
Substance Name
Pyrithione Zinc
Dosage Form
Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.
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)
PYRITHIONE ZINC 2 g/100mL
Usage Information
• Wet hair, massage shampoo into scalp, rinse thoroughly, and repeat if desired.• For best results, use at least twice a week or as directed by a doctor.• For maximum dandruff control, use every time you shampoo.

Regulatory & Marketing

Labeler Name
Dandrx Llc
Product Type
Human Otc Drug
FDA Application #
M032
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-30-2025
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 85521-002-08 identifies a specific commercial package of 237 ml in 1 bottle of Dandrx Anti-dandruff, a human over the counter drug labeled by Dandrx Llc. This shampoo is formulated for topical use and contains pyrithione zinc 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 Dandrx Llc on July 30, 2025. The current certification is valid through December 31, 2026.

How is this Dandrx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85521000208. 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)
85521-002-08
11-Digit CMS (5-4-2)
85521-0002-08

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