Quick answers
- What is Articadent?
- Articadent is a brand name of Articaine hydrochloride and epinephrine, a prescription medicine. The FDA NDC Directory lists 2 Articadent products in 2 strengths and forms.
- Who makes Articadent?
- Deproco holds the FDA application for Articadent (NDA020971, approved April 3, 2000).
- Is there a generic or store brand of Articadent?
- Yes. The FDA NDC Directory lists 18 other products with the same active ingredients, strength and form as a Articadent product, 16 of them generic. Ask your pharmacist whether one is right for you.
- Has Articadent been recalled?
- FDA enforcement reports list 1 recall of Articadent products; the newest started May 2, 2019. A recall usually concerns specific lots, not every product.
What Articadent is
Each Articadent product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Articaine hydrochloride and epinephrine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| articaine hydrochloride 40 mg/mL · epinephrine bitartrate 0.005 mg/mL injection, solution (submucosal) | Articadent | 8 products, 6 companies | DailyMed |
| articaine hydrochloride 40 mg/mL · epinephrine bitartrate 0.01 mg/mL injection, solution (submucosal) | Articadent | 10 products, 6 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Articaine hydrochloride and epinephrine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020971 | Deproco | April 3, 2000 | 2 |
Companies that list Articadent
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Articadent products.
- Dentsply Pharmaceutical2 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: 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.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.