Prescription medicine
Articaine and epinephrine Brand names: Orabloc; first approved as Septocaine
Articaine and epinephrine (Septocaine) is a prescription medicine with an FDA approval on record since 2000. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the articaine and epinephrine FDA label on DailyMed (effective March 26, 2026, Novocol Pharmaceutical of Canada, Inc.); the NDA 20971 record on Drugs@FDA; every articaine and epinephrine label on DailyMed.
Highlights of the record
FDA label of March 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageArticaine HCl and Epinephrine 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.
Forms and strengths
- 40 mg/ml / 0.01 mg/ml
- 40 mg/ml / 0.005 mg/ml
- 40 mg/ml
Injection (solution); injection.
On the market
- Earliest approval on file
- April 3, 2000 Septocaine, Deproco; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first June 18, 2010; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 0 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest May 2, 2019
- FAERS reports
- 742 through July 30, 2026
What is articaine and epinephrine used for?
From the label: indications and usageArticaine HCl and Epinephrine 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. Articaine HCl and Epinephrine 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 patients 4 years of age or older.
FDA pharmacologic class: Amide Local Anesthetic, Catecholamine, alpha-Adrenergic Agonist and beta-Adrenergic Agonist.
Source: FDA drug label (Articaine Hydrochloride and Epinephrine), NDA020971 (Deproco), as published by Novocol Pharmaceutical of Canada, Inc., effective March 26, 2026 (SPL set 636cbf11-819c-48f8-915d-ac5fb38bd352), via openFDA; the full label on DailyMed
Is there a generic for articaine and epinephrine (Septocaine)?
The FDA approved the first generic articaine and epinephrine on June 18, 2010. 3 generic applications are approved; 0 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
- 2000 earliest approval on file
- 2010 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has articaine and epinephrine been recalled?
The FDA's Enforcement Report lists 1 recall naming articaine and epinephrine since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 2, 2019 | Class II | 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 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the articaine and epinephrine label say about other medicines?
The articaine and epinephrine label names 26 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Benzocaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Bupivacaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Chloroquine | drug interactions | Class: Antimalarials; Examples: chloroquine, primaquine |
| Cyclophosphamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Dapsone | drug interactions | Class: Antibiotics; Examples: dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides |
| Flutamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Hydroxyurea | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Ifosfamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Lidocaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Mepivacaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Methylene blue | warnings and precautions | A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. |
| Metoclopramide | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Nitric oxide | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
Every other medicine the articaine and epinephrine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nitrofurantoin | drug interactions | Class: Antibiotics; Examples: dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides |
| Nitroglycerin | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
| Nitrous oxide | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
| Phenobarbital | drug interactions | Class: Anticonvulsants; Examples: phenobarbital, phenytoin, sodium valproate |
| Phenytoin | drug interactions | Class: Anticonvulsants; Examples: phenobarbital, phenytoin, sodium valproate |
| Prilocaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Primaquine | drug interactions | Class: Antimalarials; Examples: chloroquine, primaquine |
| Quinine | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Rasburicase | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Ropivacaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Sulfasalazine | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Tetracaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
Source: FDA drug label (Articaine Hydrochloride and Epinephrine), NDA020971 (Deproco), as published by Novocol Pharmaceutical of Canada, Inc., effective March 26, 2026 (SPL set 636cbf11-819c-48f8-915d-ac5fb38bd352), via openFDA; the full label on DailyMed
What do FAERS reports show for articaine and epinephrine?
The FDA Adverse Event Reporting System holds 742 reports that list articaine and epinephrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 61 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other amide local anesthetics
- the pharmacologic class, with prices and generics
- Articaine and epinephrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other