Is Dentsply Pharmaceutical Inc. FDA approved?

Dentsply Pharmaceutical Inc. holds no registered establishment of its own; 8 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Dentsply Pharmaceutical Inc. make?

8 products are listed under Dentsply Pharmaceutical Inc. in the openFDA NDC Directory, most often as injection, solution; gel. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Dentsply Pharmaceutical Inc.

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

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Registered sites: 0
Active NDC listings: 8
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

8 active NDC listings: 8 human prescription drug. By marketing category: ANDA 5, NDA AUTHORIZED GENERIC 2, NDA 1.

Dosage form	NDCs
injection, solution	7
gel	1

Route	NDCs
submucosal	7
periodontal	1

Labeller name on the listing	NDCs
dentsply pharmaceutical	6
dentsply pharmaceutical inc.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Articadent	Articaine hydrochloride and Epinephrine Bitartrate	injection, solution, submucosal	66312-601NDA AUTHORIZED GENERIC
Articadent	Articaine hydrochloride and Epinephrine Bitartrate	injection, solution, submucosal	66312-602NDA AUTHORIZED GENERIC
Citanest Forte DENTAL	prilocaine hcl and epinephrine	injection, solution, submucosal	66312-580ANDA
Citanest Plain	prilocaine hydrochloride	injection, solution, submucosal	66312-630ANDA
Oraqix	lidocaine and prilocaine	gel, periodontal	66312-110NDA
Polocaine	Mepivacaine Hydrochloride	injection, solution, submucosal	66312-441ANDA
Xylocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	injection, solution, submucosal	66312-176ANDA
Xylocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	injection, solution, submucosal	66312-181ANDA

Enquiry

Common questions

Is Dentsply Pharmaceutical Inc. FDA approved?: Dentsply Pharmaceutical Inc. holds no registered establishment of its own; 8 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Dentsply Pharmaceutical Inc. make?: 8 products are listed under Dentsply Pharmaceutical Inc. in the openFDA NDC Directory, most often as injection, solution; gel. 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.