Standardized Chemical AllergenOTC AvailablePregnancy Cat. Not classifiedFDA Yes
Oral Pain Relief
BENZOCAINE AND BENZALKONIUM CHLORIDE
Use ■ for the temporary relief of pain due to toothaches ■ to help protect against infection in minor oral irritation
Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians ·
Brand names:Oral Pain Relief
Quick Reference
Medicine ClassStandardized Chemical Allergen
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- BENZOCAINE AND BENZALKONIUM CHLORIDE
- Medicine class
- Standardized Chemical Allergen
- Brand names
- Oral Pain Relief
- Availability
- Over-the-counter (OTC)
- Pregnancy category
- Not classified
- FDA approved
- Yes
Medical Review
Medically reviewed- Reviewed by
- MedCentralHub Medical Review Board
- Credentials
- Licensed Pharmacists & Physicians
- Last reviewed
- Next review
Written from primary sources (FDA labeling, NIH/MedlinePlus, peer-reviewed literature) and verified by our review board. Educational information only — not a substitute for professional medical advice. See our medical disclaimer.
What Is Oral Pain Relief?
Use ■ for the temporary relief of pain due to toothaches ■ to help protect against infection in minor oral irritation
Oral Pain Relief (BENZOCAINE AND BENZALKONIUM CHLORIDE) belongs to the Standardized Chemical Allergen class of medications. It was first approved by the FDA in Yes. This medication is available over-the-counter without a prescription.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Oral Pain Relief. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Oral Pain Relief with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Oral Pain Relief is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
Use ■ for the temporary relief of pain due to toothaches ■ to help protect against infection in minor oral irritation
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
Directions ■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider ■ children under 12 years of age: should be supervised in the use of this product ■ children under 2 years of age: Do not use
Available Forms
Available Strengths
Side Effects
Common
Serious
- Warnings Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce the amount of oxygen carried in blood.
- This can occur even if you have used this product before.
- Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadness • fatigue or lack of energy Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
Warnings Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce the amount of oxygen carried in blood. This can occur even if you have used this product before.
How Oral Pain Relief Works
Pharmacokinetics
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Oral Pain Reliefwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Oral Pain Relief
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Sources & References
Content on this page is drawn from the following primary sources and reviewed against current labeling.
- FDA DailyMed — Official FDA prescribing information and drug labels
- MedlinePlus (NIH) — Patient-friendly drug information from the National Library of Medicine
- FDA Drug Safety Communications — Current FDA safety alerts, recalls, and label changes
- PubMed — Peer-reviewed clinical literature
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.