Royal Oils By Head And Shoulders Sulfate Free Scalp Care Shampoo
NDC Package 69423-608-38

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

Package Information

Royal Oils By Head And Shoulders Sulfate Free Scalp Care (pyrithione zinc) shampoos is for best results use at least twice a week or as directed by a doctor. This formulation utilizes a shampoo delivery system. Marketed by The Procter & Gamble Manufacturing Company, this product is identified by NDC 69423-608 and is authorized under FDA application M032.

Identification & Billing

NDC Package Code
69423-608-38
Package Description
380 mL in 1 BOTTLE, PLASTIC
Product Code
69423-608
11-Digit Billing Format
69423060838
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Royal Oils By Head And Shoulders Sulfate Free Scalp Care
Non-Proprietary Name
Pyrithione Zinc
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 1 g/100mL
Usage Information
For best results use at least twice a week or as directed by a doctor. for maximum dandruff control, use every time you shampoo.shake before use.wet hair, massage onto scalp, rinse, repeat if desired. for best results use at least twice a week or as directed by a doctor. apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.

Regulatory & Marketing

Labeler Name
The Procter & Gamble Manufacturing Company
Product Type
Human Otc Drug
FDA Application #
M032
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-30-2021
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 69423-608-38 identifies a specific commercial package of 380 ml in 1 bottle, plastic of Royal Oils By Head And Shoulders Sulfate Free Scalp Care, a human over the counter drug labeled by The Procter & Gamble Manufacturing Company. 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 The Procter & Gamble Manufacturing Company on October 30, 2021. The current certification is valid through December 31, 2026.

How is this The Procter & Gamble Manufacturing Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69423060838. 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)
69423-608-38
11-Digit CMS (5-4-2)
69423-0608-38

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