Xylocaine

Dentsply Pharmaceutical🇺🇸 United States

FDA Page

Effective Date: Aug 13, 2026
Approval ID: 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1
Products: 2 registered
Version: 10

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

2% XylocaineDENTAL with Epinephrine 1:50,000(Lidocaine Hydrochloride and Epinephrine Injection, USP)Lidocaine HCl 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:50,000 Injection 2% XylocaineDENTAL with Epinephrine 1:100,000(Lidocaine Hydrochloride and Epinephrine Injection, USP)Lidocaine HCl 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:100,000 Injection

Quick Stats

Total Products2

Labelers2

Label Sections25

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.