Drugplain

CankerMelts 15 mg/1

benzocaine · LOZENGE · Quest Products, LLC

No Recall History
Plain English

CankerMelts is a lozenge containing benzocaine at 15 mg/1, taken oral. Manufactured by Quest Products, LLC.

Key Facts

Brand Name
CankerMelts
Generic Name
benzocaine
NDC Code (Product)
68229-700
Manufacturer
Quest Products, LLC
Strength
15 mg/1
Dosage Form
LOZENGE
Route
ORAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
10/06/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

methaemoglobinaemia124 reports
drug ineffective89 reports
drug hypersensitivity61 reports
off label use59 reports
asthenia48 reports
nausea47 reports
dyspnoea38 reports
arthralgia36 reports
anxiety35 reports
amnesia33 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for temporary relief of pain associated with: canker sores minor irritation mouth sores

Dosage & Administration

Directions Adults and children age 5 and older: Affix one tablet as directed below and allow to slowly dissolve in the mouth. May be repeated every 2 hours as needed or directed by a doctor or dentist. This product may last over 2 hours. Placement: CankerMelts are bi-layered tablets with a dimple on the adhesive side and a pain reliever on the domed side marked CM. Place the adhesive side with a dimple against teeth or gums or braces or appliance. Place opposite or adjacent to the sore. Hold tablet in place with your cheek or tongue for 10 seconds to initiate adhesion. Adhesion will strengthen over the next few minutes. It may be removed at any time. Children under 5 years of age: Do not use.

Warnings

Warnings Methemoglobinemea warning: Use of this product may cause methemoglobinemea, a serious- condition that must be treated promptly because it reduces 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 lightheadedness 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, benzocaine, or other "caine" anesthetics. Do not use: this product for more than 7 days unless directed by a doctor or dentist in children under 5 years of age When using this product do not exceed recommended dosage. Stop use and ask a doctor or dentist if: if sore mouth symptoms do not improve in 7 days if irritation, pain, or redness persists or worsens if swelling, rash or fever develops If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children in case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is CankerMelts used for?

CankerMelts contains benzocaine. It is a lozenge taken oral. Consult your doctor for specific uses.

Is CankerMelts a controlled substance?

CankerMelts is not classified as a controlled substance by the DEA.

What is the generic name for CankerMelts?

The generic name for CankerMelts is benzocaine. There are 12 other brand versions of benzocaine.

What is the NDC code for CankerMelts 15 mg/1?

The NDC (National Drug Code) for CankerMelts 15 mg/1 is 68229-700, listed by Quest Products, LLC.