Drugplain

ARTICAINE 40 mg/mL

Articaine Hydrochloride and Epinephrine · INJECTION, SOLUTION · Benco Dental

1 Recall on Record
Plain English

ARTICAINE is a injection, solution containing articaine hydrochloride and epinephrine at 40 mg/mL, taken submucosal. Manufactured by Benco Dental.

Key Facts

Brand Name
ARTICAINE
Generic Name
Articaine Hydrochloride and Epinephrine
NDC Code (Product)
66975-418
Manufacturer
Benco Dental
Strength
40 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Marketing Status
Application #
NDA020971
Marketing Start
04/04/2016

Recall History

1 Recall on Record
Class II05/02/2019

Septodont Inc.

Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

electrocardiogram st segment elevation17 reports
hypoxia15 reports
overdose14 reports
drug ineffective11 reports
hypoaesthesia11 reports
hypoaesthesia oral11 reports
cardiac arrest10 reports
nausea10 reports
toxicity to various agents10 reports
arrhythmia9 reports

Frequently Asked Questions

What is ARTICAINE used for?

ARTICAINE contains Articaine Hydrochloride and Epinephrine. It is a injection, solution taken submucosal. Consult your doctor for specific uses.

Is ARTICAINE a controlled substance?

ARTICAINE is not classified as a controlled substance by the DEA.

What is the generic name for ARTICAINE?

The generic name for ARTICAINE is Articaine Hydrochloride and Epinephrine. There are 7 other brand versions of Articaine Hydrochloride and Epinephrine.

What is the NDC code for ARTICAINE 40 mg/mL?

The NDC (National Drug Code) for ARTICAINE 40 mg/mL is 66975-418, listed by Benco Dental.

Product NDC

66975-418

Package NDC

66975-418-51

Other Articaine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)