Is Royal Pharmaceuticals, LLC FDA approved?

Royal Pharmaceuticals, LLC holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Royal Pharmaceuticals, LLC make?

3 products are listed under Royal Pharmaceuticals, LLC in the openFDA NDC Directory, most often as oil. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Royal Pharmaceuticals, LLC

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 3
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: NDA 3.

Dosage form	NDCs
oil	3

Route	NDCs
topical	2
auricular (otic)	1

Labeller name on the listing	NDCs
royal pharmaceuticals	2
royal pharmaceuticals, llc	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
DERMA-SMOOTHE/FS	fluocinolone acetonide	oil, topical	68791-102NDA
DERMOTIC	fluocinolone acetonide	oil, auricular (otic)	68791-103NDA
Derma-Smoothe/FS	fluocinolone acetonide	oil, topical	68791-101NDA

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Enquiry

Common questions

Is Royal Pharmaceuticals, LLC FDA approved?: Royal Pharmaceuticals, LLC holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Royal Pharmaceuticals, LLC make?: 3 products are listed under Royal Pharmaceuticals, LLC in the openFDA NDC Directory, most often as oil. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.