Quick answers
- What is Articaine hydrochloride and epinephrine used for?
- The FDA-approved label (Articadent, Dentsply Pharmaceutical, March 1, 2024) says: “ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older. ARTICADENT is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Articaine hydrochloride and epinephrine have a boxed warning?
- No. None of the 19 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Articaine hydrochloride and epinephrine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Articaine hydrochloride and epinephrine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started May 2, 2019 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Articaine hydrochloride and epinephrine?
- 11 companies list prescription products of Articaine hydrochloride and epinephrine in the FDA NDC Directory, including Novocol Pharmaceutical of Canada, Inc., Septodont, Inc. and Burkhart Dental Supply Co., Inc.
What Articaine hydrochloride and epinephrine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older. ARTICADENT is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric …
— FDA label: Articadent, Dentsply Pharmaceutical, effective March 1, 2024. Read the full label on DailyMed →
The FDA has 19 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 19 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Submucosal |
| Prescription products | 28 in the FDA NDC Directory |
| Brand names | Articadent, Septocaine and Epinephrine, Orabloc, Zorcaine |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Novocol Pharmaceutical of Canada, Inc.7 products
- Septodont, Inc.3 products
- Burkhart Dental Supply Co., Inc2 products
- Patterson Dental2 products
- Benco Dental2 products
- Henry Schein2 products
- NDC, Inc.2 products
- Dentsply Pharmaceutical2 products
- Safco Dental Supply Co.2 products
- Pierrel S.p.A.2 products
- Aira LLC2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020971 SEPTOCAINE | Deproco | April 3, 2000 | 17, latest November 2, 2018 2018: Labeling · 2017: Manufacturing (CMC) · 2016: Manufacturing (CMC) |
| NDA022466 ORABLOC | Pierrel | February 26, 2010 | 4, latest July 2, 2025 2025: Labeling · 2018: Labeling · 2014: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 2, 2019 · Class II · Terminated · D-1307-2019
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 D
Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-6 — Septodont Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Articadent, Dentsply Pharmaceutical, effective March 1, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →