Oraqix

Dentsply Pharmaceutical🇺🇸 United States

FDA Page

Effective Date: Apr 21, 2026
Approval ID: b501d239-923b-48b2-82ed-6c5c253a67e2
Products: 1 registered
Version: 12

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ORAQIX safely and effectively. See full prescribing information for ORAQIX. ORAQIX (lidocaine and prilocaine periodontal gel) 2.5%/2.5% Initial U.S. Approval: 2003

Quick Stats

Total Products1

Labelers2

Label Sections19

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.