FDA-filed SPL labeling · retrieved through openFDA

Articaine / Epinephrine

Articaine/epinephrine is a dental local anesthetic combination injection used to numb the mouth for simple and complex dental procedures in adults and children age 4 and older.

Brand names ArticadentSeptocaine and EpinephrineZorcaineOrabloc
Drug classes ⓘ Amide Local Anesthetic
Rx Form 1 Routes Submucosal · Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 19 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMar 1, 2024
Clinical labels in scope ⓘ19
AvailabilityRx
Earliest approval/marketing year ⓘ2009
FDA-listed product records ⓘ56
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 23, 2026
⭐ Articaine / Epinephrine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Articaine/epinephrine is a fast-acting dental numbing injection used safely in millions of dental procedures each year for both adults and children 4 and older. It's given entirely by your dental provider, so your main job is to tell them about all your medications, allergies, and health conditions beforehand. Most side effects are mild and temporary, but let your dentist know right away if you notice anything unusual — like lasting numbness, vision changes, or skin turning bluish — after the procedure.
How we write & review this content — our editorial policy →

📖 Articaine / Epinephrine: Patient Information Guide

A plain-language walkthrough of Articaine / Epinephrine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Articaine/epinephrine is a dental local anesthetic injection approved for numbing during a wide range of dental procedures. All supported products share the same core indication:

  • Local, infiltrative, or conductive (nerve block) anesthesia for simple dental procedures such as fillings and extractions — approved for adults and children age 4 and older
  • Local, infiltrative, or conductive anesthesia for complex dental procedures and oral surgery — approved for adults and children age 4 and older
  • Articadent (submucosal injection) is indicated for both simple and complex dental anesthesia in adults and pediatric patients 4 years and older
  • Orabloc (submucosal injection) is indicated for both simple and complex dental anesthesia in adults and pediatric patients 4 years and older
  • Septocaine and Epinephrine (subcutaneous/submucosal injection) is indicated for both simple and complex dental anesthesia in adults and pediatric patients 4 years and older
⚙️How it works▾

Articaine belongs to a class of drugs called amide local anesthetics. It works by blocking nerve impulses in the area where it's injected — raising the threshold for nerve firing, slowing down signal transmission, and preventing pain signals from reaching the brain. The result is a predictable, temporary loss of sensation. Epinephrine is added as a vasoconstrictor (blood vessel tightener): by narrowing local blood vessels, it slows how fast articaine is absorbed into the general circulation, keeping the numbing effect stronger and longer-lasting right where it's needed.

💊How it's taken▾

Articaine/epinephrine is always administered by a trained dental professional — it is not taken at home. It is injected directly into the tissues inside the mouth (submucosal infiltration) or around a specific nerve (nerve block), depending on what part of the mouth needs to be numbed and how extensive the procedure is.

  • Infiltration injections provide anesthesia lasting approximately 1 hour
  • Nerve block injections can provide anesthesia lasting up to approximately 2 hours
  • The dose is determined by your dental provider based on the procedure, your weight, age, and overall health
  • Elderly patients, children, and patients who are unwell typically receive lower doses
🤒Side effects — in detail▾

The most common side effects reported in clinical trials include:

  • Pain at or near the injection site
  • Headache
  • Facial swelling
  • Numbness or tingling that lingers beyond the procedure
  • Nausea
  • Sleepiness
  • Heart palpitations
  • Trismus (jaw stiffness or difficulty opening the mouth)

More serious reactions — including seizures, difficulty breathing, bluish skin discoloration, lasting facial or tongue numbness, or vision changes like double vision — require immediate medical attention. Tell your dental provider right away if anything feels wrong during or after your injection.

⚠️Warnings & precautions▾
  • Accidental injection into a blood vessel is the most serious risk. It can trigger seizures, coma, dangerously abnormal heart rhythms, and cardiac arrest. Dental providers are trained to prevent this, but emergency equipment should always be available.
  • Systemic toxicity: if too much articaine or epinephrine is absorbed into the bloodstream, it can affect the heart and nervous system — causing arrhythmias (irregular heartbeat), low blood pressure, or central nervous system symptoms like dizziness, tremors, and confusion.
  • Methemoglobinemia (a condition where blood can't carry oxygen properly): rare but serious. Signs include bluish or grayish skin. People with certain enzyme deficiencies, infants, and those on certain other medications are at higher risk.
  • Epinephrine-related risks: the vasoconstrictor can cause local tissue damage due to blood vessel spasm, and should be used very carefully in patients with heart disease, high blood pressure, or blood vessel problems.
  • Prolonged numbness: persistent loss of sensation in the lips, tongue, or mouth tissues has been reported, particularly after lower jaw nerve blocks, and may be slow to resolve or permanent in some cases.
  • Sulfite allergy: this product contains sodium metabisulfite; it must not be used in people with sulfite hypersensitivity, and should be used with extra caution in asthmatic patients.
🔀What it interacts with▾

Because this medication contains epinephrine, it can interact significantly with several drug classes. Always tell your dental provider about every medication you take:

  • MAO inhibitors (used for depression or Parkinson's disease): combining with epinephrine can cause severely and dangerously elevated blood pressure
  • Nonselective beta-blockers (used for heart conditions or high blood pressure): can lead to severe, prolonged high blood pressure with epinephrine
  • Tricyclic antidepressants (e.g., amitriptyline, nortriptyline): same risk of severe high blood pressure with epinephrine
  • Phenothiazines and butyrophenones (antipsychotic medications): can blunt or reverse the intended effect of epinephrine on blood vessels
  • Other local anesthetics, nitrates, certain antibiotics (like dapsone), anticonvulsants, antimalarials, acetaminophen, and metoclopramide: concurrent use raises the risk of methemoglobinemia

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Sulfite allergy: do not use if you have a known hypersensitivity to sulfites — this is a contraindication
  • Asthma: sulfite sensitivity is more common in people with asthma; tell your dentist
  • Heart conditions or blood vessel disease: epinephrine must be used with extra caution; inform your dental provider of any cardiac history
  • Liver disease: no studies have been done in patients with severe hepatic impairment; caution is warranted
  • Kidney disease: no studies have been done in patients with renal impairment; inform your provider
  • Pregnancy: animal studies showed potential fetal harm at high doses; use only when the potential benefit justifies the risk — discuss with your dentist and obstetrician
  • Breastfeeding: it is unknown whether articaine passes into breast milk; nursing mothers may choose to pump and discard breast milk for approximately 4 hours after injection, then resume breastfeeding
  • Children under 4 years: safety and effectiveness have not been established in this age group
  • Older adults, debilitated, or acutely ill patients: lower doses are recommended; sensitivity may be greater
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency or congenital methemoglobinemia: heightened risk of methemoglobinemia; close monitoring required if use is necessary
🚑If you take too much▾

Too much articaine/epinephrine in the bloodstream — whether from too large a dose or accidental injection into a blood vessel — can cause seizures, dangerously slow or irregular heartbeat, very low blood pressure, and, if untreated, cardiac arrest. The first steps are maintaining an open airway, providing oxygen, and monitoring breathing and heart function closely. If seizures don't stop with supportive care, anticonvulsant medication may be needed, and circulation may require IV fluids or vasopressor drugs. If you suspect an overdose situation, call Poison Control at 1-800-222-1222 or seek emergency care immediately.

📡Pharmacodynamics — effects in the body▾

After injection, articaine/epinephrine produces a predictable sequence of numbing: pain sensation goes first, followed by temperature, touch, the sense of body position, and finally muscle tone. Onset of anesthesia typically occurs within 1 to 9 minutes of injection. Infiltration anesthesia lasts approximately 1 hour, while nerve block anesthesia can last up to about 2 hours. The injection causes a 3- to 5-fold rise in blood epinephrine levels compared to baseline, but in healthy adults this generally does not produce noticeable increases in heart rate or blood pressure — unless the drug is accidentally injected into a blood vessel.

🔬Pharmacokinetics — how your body processes it▾

After a submucosal dental injection, articaine reaches its peak blood level in about 25 minutes for a single dose, or around 48 minutes when multiple doses are given. The drug is 60–80% bound to proteins in the blood (mainly albumin). Articaine is broken down primarily by enzymes in the blood plasma into an inactive substance called articainic acid; the liver plays only a minor role. The elimination half-life (the time it takes for half the drug to leave the body) is roughly 44 minutes, and most of the drug is cleared through the urine within 24 hours of injection.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) . Protect from light. Do not freeze.

📄 Written from Articaine / Epinephrine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Articaine / Epinephrine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is articaine/epinephrine and why is my dentist using it? ▾
It's the numbing injection your dentist gives you before a filling, extraction, or other dental work. Articaine is the anesthetic that blocks pain signals in your mouth, and epinephrine is added to make the numbing last longer by keeping the medication from being absorbed too quickly into your bloodstream. It's been used safely in dental offices for many years and works for both routine and more involved procedures.
How long will my mouth stay numb after the injection? ▾
That depends on the type of injection. If it's injected directly into the tissue near the tooth (infiltration), the numbness usually lasts about 1 hour. If your dentist needs to block a larger nerve — like for lower jaw work — it can last up to about 2 hours. Everyone's a little different, so your dentist can give you a better estimate based on what's being done.
What side effects should I watch for after I leave the dentist's office? ▾
The most common things people notice are soreness or pain where the injection was given, a headache, and some residual numbness or tingling. These are usually mild and go away on their own. What you really want to watch for — and call your dentist or go to urgent care about — is numbness that doesn't go away after several hours, double vision, difficulty opening your mouth, or any bluish coloring of your skin, which is rare but serious. Also call right away if you had any unusual symptoms while still at the office that weren't addressed.
I take an antidepressant. Is that a problem with this injection? ▾
Possibly — it depends on which type. Certain antidepressants, especially older ones called tricyclic antidepressants (like amitriptyline) and MAO inhibitors, can interact with the epinephrine in this injection and cause a spike in blood pressure. Make sure your dentist knows every medication you take before any procedure. They can plan accordingly and use the lowest effective amount of epinephrine.
Is this safe if I'm pregnant or breastfeeding? ▾
If you're pregnant, this medication should only be used when your dentist and doctor agree the benefit outweighs any risk — animal studies at high doses showed potential harm to the fetus, though those doses were much higher than what's used in dental practice. If you're breastfeeding, one reasonable precaution is to pump and discard your breast milk for about 4 hours after the injection before nursing again, since we don't know for certain whether the drug passes into breast milk. Talk to both your dentist and your OB before your appointment.
Can my child receive this injection? ▾
Yes, for children 4 years and older — it is approved for kids that age and up for both simple and complex dental procedures. It has not been established as safe for children under 4. Your child's dentist will use a lower dose based on their weight and age, and will monitor them carefully. One thing to watch out for at home afterward: young children may accidentally bite or chew their numb lip or cheek without realizing it, which can cause minor injuries, so keep an eye on them until the numbness wears off.
Is Articaine / Epinephrine available over the counter? ▾
Articaine / Epinephrine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Articaine / Epinephrine first available? ▾
Articaine / Epinephrine has been available in the United States since at least 2009, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Articaine / Epinephrine? ▾
Articaine / Epinephrine is supplied by 12 manufacturers listed in the FDA NDC Directory, including Novocol Pharmaceutical of Canada, Inc., Henry Schein, NDC, Inc..

💬 Answers drafted from Articaine / Epinephrine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

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💊 How Articaine / Epinephrine comes

Articaine / Epinephrine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Submucosal · Under the skin
Brands Articadent Orabloc Septocaine and Epinephrine Zorcaine
How this form is used
What it may be used for
  • Used for local anesthesia (numbing) during simple and complex dental procedures in adults and children 4 years of age and older
  • Articadent is indicated for local, infiltrative, or conductive dental anesthesia via submucosal injection
  • Orabloc is indicated for local, infiltrative, or conductive dental anesthesia via submucosal injection
  • Septocaine and Epinephrine is indicated for local, infiltrative, or conductive dental anesthesia via subcutaneous or submucosal injection
Important instructions
  • Given by a dental professional as an intraoral injection — into or beneath the tissues of the mouth — not self-administered
  • Articadent: the 1:200,000 epinephrine concentration is preferred for most routine dental procedures; the 1:100,000 concentration may be used when better control of bleeding or a clearer surgical field is needed
  • Orabloc: the 1:200,000 epinephrine concentration is preferred for routine procedures; the 1:100,000 concentration may be used when improved visualization or more pronounced hemostasis is required
  • Septocaine and Epinephrine: the 1:200,000 epinephrine concentration is preferred for most routine procedures; the 1:100,000 concentration may be used when greater hemostasis or surgical field clarity is needed
Available strengths 4 strengths
40 mg/mL / 0.005 mg/mL 40 mg/mL / 0.01 mg/mL 40 mg/mL / 5 mcg/mL 40 mg/mL / 10 mcg/mL
56 FDA-listed product records ⓘ

📊 Articaine / Epinephrine across the U.S. market

How Articaine / Epinephrine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
12
Manufacturers
7
Brand names
56
FDA-listed product records ⓘ
2009
First marketed ⓘ
Novocol Pharmaceutical of Canada, Inc.13%
Henry Schein11%
NDC, Inc.11%
Patterson Dental11%
Dentsply Pharmaceutical11%
Benco Dental11%
Other makers34%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

🔍 Compare Articaine / Epinephrine products

A representative set of FDA-listed product records for Articaine / Epinephrine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 56 of 56 products — FDA National Drug Code Directory. See every product, package size and price: browse all 56 Articaine / Epinephrine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Articaine / Epinephrine RxCUI 284622 1 dose form · 6 strengths
  1. Dose form (SCDF) Cartridge RxCUI 1658945 No current FDA listing
    Clinical drug / strength (SCD) 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML RxCUI 1595029 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML RxCUI 1595035 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine bitartrate 0.009 MG/ML RxCUI 1928853 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine bitartrate 0.018 MG/ML RxCUI 1928862 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML RxCUI 1658966 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML RxCUI 1661483

Look up RxCUI 284622 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Articadent Septocaine and Epinephrine Zorcaine Orabloc

🏭 Manufacturers & labelers

Novocol Pharmaceutical of Canada, Inc. 7 Henry Schein 6 NDC, Inc. 6 Patterson Dental 6 Dentsply Pharmaceutical 6 Benco Dental 6 Septodont Inc. 4 Safco Dental Supply Co. 4 Midway Dental Supply, LLC 4 Septodont, Inc. 3 Pierrel S.p.A. 2 Burkhart Dental Supply Co., Inc 2

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 1, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Articaine / Epinephrine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Articaine / Epinephrine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
19
NDC products indexed
56
Distinct labelers/manufacturers represented
12
Linked representative label ⓘ
Dentsply Pharmaceutical
Linked label effective
Mar 1, 2024
Composite sections available
24
Linked SPL Set ID
9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00
Linked SPL Document ID
7b56ec0a-5b85-4069-a3b2-94654644aaa4
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 19 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Dentsply Pharmaceutical is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.