Derma-smoothe/fs Oil
NDC Package 68791-101-01

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

Package Information

Derma-smoothe/fs (fluocinolone acetonide) oils is this shampoo is used to treat severe dandruff (seborrheic dermatitis). This formulation utilizes a oil delivery system. Marketed by Royal Pharmaceuticals, Llc, this product is identified by NDC 68791-101 and is authorized under FDA application NDA019452.

Identification & Billing

NDC Package Code
68791-101-01
Package Description
1 BOTTLE in 1 CARTON / 20 mL in 1 BOTTLE
Product Code
68791-101
11-Digit Billing Format
68791010101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Derma-smoothe/fs
Non-Proprietary Name
Fluocinolone Acetonide
Substance Name
Fluocinolone Acetonide
Dosage Form
Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
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)
FLUOCINOLONE ACETONIDE .11 mg/mL
Pharmacologic Class
Usage Information
This shampoo is used to treat severe dandruff (seborrheic dermatitis). Fluocinolone reduces the swelling, itching, flaking, and redness that can occur with dandruff. This medication is a low- to medium-strength corticosteroid.

Regulatory & Marketing

Labeler Name
Royal Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA019452
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-16-1995
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68791-101). Click a package code to view its specific billing and regulatory data.

68791-101-04
1 BOTTLE in 1 CARTON / 118.28 mL in 1 BOTTLE

* 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 68791-101-01 identifies a specific commercial package of 1 bottle in 1 carton / 20 ml in 1 bottle of Derma-smoothe/fs, a human prescription drug labeled by Royal Pharmaceuticals, Llc. This oil is formulated for topical use and contains fluocinolone acetonide 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 Royal Pharmaceuticals, Llc on February 16, 1995. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This shampoo is used to treat severe dandruff (seborrheic dermatitis). Fluocinolone reduces the swelling, itching, flaking, and redness that can occur with dandruff. This medication is a low- to medium-strength corticosteroid.

How is this Royal Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68791010101. 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)
68791-101-01
11-Digit CMS (5-4-2)
68791-0101-01

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