Pronunciation: Oh-rah-gel
Dosage form: Topical gel, topical cream, topical swabs, topical liquid
Drug class: Topical anesthetics

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 8, 2024.

What is Orajel?

Orajel is a topical treatment for the mouth and gums that may be used to relieve pain associated with minor mouth problems. Orajel is available as a medicated or nonmedicated formulation.

• Medicated formulations of Orajel contain benzocaine and are intended for use by adults and children over the age of 12.  They can be used by children aged 2 to 12 years if under the guidance of a doctor and an adult supervising how much they use. Because benzocaine numbs the skin or surfaces inside the mouth it can be effective at temporarily relieving pain caused by a sore throat, canker sores, cold sores, fever blisters, minor irritation, or injury of the mouth and gums.
• Nonmedicated formulations of Orajel (such as Orajel Baby) do not contain benzocaine. They are also free of artificial colors and sweeteners, menthol, parabens, belladonna, sodium lauryl sulfate (SLS), gluten, dairy, and eugenol (clove oil). These products are marketed for use during teething; however, the American Academy of Pediatrics (AAP) discourages their use because they wash out of the baby’s mouth within minutes and may present safety concerns. Instead, the AAP suggests using a teething ring made of firm rubber (not frozen) or gently rubbing or massaging the child’s gums with a finger to relieve symptoms.

Benzocaine is a local anesthetic (numbing medication) that works by blocking nerve signals in your body. The use of topical benzocaine has been associated with methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a), which is a potentially life-threatening condition that affects how red blood cells deliver oxygen around your body. This is why topical medicated Orajel products now display a warning about methemoglobinemia and why the FDA has said these products should not be used by children under the age of 2.

Signs and symptoms of methemoglobinemia may include pale, gray- or blue-colored skin, lips, and nail beds; shortness of breath; fatigue; headache; lightheadedness; or a rapid heart rate. Symptoms may occur the first time you use benzocaine or after many uses, and may appear within minutes to 1 to 2 hours. If any symptoms occur, the person should receive medical attention immediately.

Warnings

Use of medicated Orajel products containing benzocaine has been associated with potentially fatal methemoglobinemia. Do not use this medicine if you have ever had methemoglobinemia. Do not use benzocaine-containing topical products in children under the age of 2.

GET EMERGENCY MEDICAL HELP IF YOU HAVE SYMPTOMS OF METHEMOGLOBINEMIA, such as a headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

An overdose of benzocaine can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This can happen if you apply more than the recommended dose. Use the smallest amount needed, even in adults and older children.

Do not use medicated Orajel products that contain benzocaine if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics.

Do not use medicated Orajel products on a child younger than 2 years old.

Before taking this medicine

Do not use medicated Orajel if you have ever had methemoglobinemia in the past.

Ask a doctor or pharmacist if Orajel is safe to use if you:

• have a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency disorder
• have asthma, bronchitis, emphysema, or other breathing disorder
• have heart disease
• smoke
• are pregnant or breast-feeding.

How should I use Orajel?

Use Orajel exactly as directed on the label, or as prescribed by your doctor. Read all medication guides or instruction sheets. Do not use more than is recommended. Use the smallest amount needed to numb the skin or relieve pain. Your body may absorb more benzocaine if you use too much, or if you apply it over large areas.

Seek emergency help if you develop symptoms of methemoglobinemia. Call your doctor if your mouth symptoms do not improve or if they get worse within the first 7 days of using Orajel. Also, call your doctor if your symptoms have cleared up but then come back.

What happens if I miss a dose?

Since Orajel is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as a pale, blue, or gray appearance of your skin, lips, or fingernails; uneven heartbeats; seizures (convulsions); coma; slowed breathing; or respiratory failure (breathing stops).

What should I avoid while using Orajel?

Avoid eating within 1 hour after using Orajel on your gums or inside your mouth.

Avoid getting Orajel in your eyes. Avoid swallowing the gel while applying it to your gums or the inside of your mouth.

What are the side effects of Orajel?

Orajel used in the mouth may cause a condition in which the oxygen in your body tissues can become dangerously low. This is a potentially fatal condition called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a). This condition may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using Orajel in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• a headache, tiredness, confusion
• fast heartbeats
• feeling light-headed or short of breath
• pale, blue, or gray appearance of your skin, lips, or fingernails.

Get emergency medical help if you have signs of an allergic reaction to Orajel, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• severe burning, stinging, or sensitivity where the medicine is applied
• swelling, warmth, or redness or
• oozing, blistering, or any signs of infection.

Common Orajel side effects may include:

• mild stinging, burning, or itching where the medicine is applied
• skin tenderness or redness or
• dry white flakes where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

What other drugs will affect Orajel?

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Storage

Store at room temperature away from moisture and heat. Do not freeze.

Ingredients

Nonmedicated formulations

Orajel Baby Daytime + Nighttime Cooling Gels for Teething. Daytime Gel: water, sorbitol, propylene glycol, glycerin, cellulose gum, poloxamer 407, flavor, potassium sorbate, simethicone, sodium saccharin, and citric acid.
              
Orajel Baby Daytime + Nighttime Cooling Gels for Teething. Nighttime Gel: water, sorbitol, propylene glycol, glycerin, cellulose gum, poloxamer 407, flavor, potassium sorbate, simethicone, sodium saccharin, chamomile, citric acid.

Orajel Baby Daytime Cooling Tablets for Teething with Vitamin D: vitamin D (as cholecalciferol) 1mcg (per 2 tablets), dried glucose syrup, microcrystalline cellulose, natural and artificial flavor, magnesium stearate, chamomile extract.

Orajel Baby Daytime Cooling Swabs for Teething: water, glycerin, propylene glycol, flavor, sodium saccharin, poloxamer 407, sodium benzoate, potassium sorbate, sorbic acid.

Medicated formulations

Orajel 4X Medicated for Toothache & Gum Cream: benzocaine 20%, menthol 0.26%, benzalkonium chloride 0.13%, zinc chloride 0.15%, ammonium glycyrrhizate, flavor, PEG-8, PEG-75, PEG/PPG 116/66 copolymer, poloxamer 407, sodium saccharin, sorbic acid, titanium dioxide, water.

Orajel PM 4X Medicated for Toothache & Gum Cream: benzocaine 20%, menthol 0.26%, benzalkonium chloride 0.13%, zinc chloride 0.15%, ammonium glycyrrhizate, chamomile, flavor, PEG-8, PEG-75, PEG/PPG 116/66 copolymer, poloxamer 407, sodium saccharin, sorbic acid, titanium dioxide, water.

Orajel 4X Medicated for Toothache & Gum Gel: benzocaine 20%, menthol 0.5%, benzalkonium chloride 0.13%, zinc chloride 0.15%, ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water.

Orajel 3X Medicated for Toothache & Gum Gel: benzocaine 20%, menthol 0.26%, zinc chloride 0.15%, ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water.

Orajel 3X Medicated for Gum Pain Gel: benzocaine 20%, menthol 0.26%, zinc chloride 0.15%, ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water.

Orajel Medicated For Toothache & Gum Liquid: benzocaine 20%, menthol 0.1%, alcohol (54.5% by volume), flavor, PEG-8, red 40, sodium saccharin, water, yellow 5.

Orajel Toothache Rinse: benzyl alcohol 0.27%, zinc chloride 0.15%, alcohol (4.1% by volume), blue 1, disodium pyrophosphate, menthol, methyl salicylate, poloxamer 338, polysorbate 20, sodium benzoate,  sodium saccharin, sorbitol, tetrasodium pyrophosphate, water.

Orajel Medicated for Toothache Gel: benzocaine 10%, ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid.

Orajel Maximum Toothache Relief Double Medicated Gel: benzocaine 20%, menthol 0.26%, ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid.

Manufacturer

Church & Dwight Co., Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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