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lozenges

Lozenge

Cepacol Extra Strength Sore Throat honey lemon

Benzocaine 15 mg, Menthol, Unspecified Form 2.6 mg

Over the counterMonograph M022

The listing

NDC product code
63824-732 (labeller 63824, product 732)
Labeller
Reckitt Benckiser LLC
Brand name
Cepacol Extra Strength Sore Throat honey lemon
Generic name
Benzocaine and Menthol
Dosage form
Lozenge
Route
oral
Marketing category
OTC MONOGRAPH DRUG M022
Marketing start
15 July 2013
Listing expires
31 December 2027
Pharmacologic class
Standardized Chemical Allergen [EPC]
RxNorm concept
858664

Active ingredients

IngredientStrengthOther listings
Benzocaine15 mg35
Menthol, Unspecified Form2.6 mg34

Strengths as listed in the FDA National Drug Code Directory, retrieved 4 September 2026. "Other listings" counts every other product on this site containing the same ingredient at any strength.

What the label claims

These are read from this product's own label, not assigned by us and not inferred from the ingredient.

Stated purposeOral anesthetic

Stated useSore throatMinor throat irritationSore mouth, gums and canker sores

Drug Facts, as filed

Quoted from the label FDA holds for this product. Long fields are truncated. The panel printed on the package you are holding is the one that governs.

Active ingredient
(in each lozenge) Purposes Benzocaine 15 mg Oral pain reliever Menthol 2.6 mg Oral pain reliever
Purpose
Active ingredients (in each lozenge) Purposes Benzocaine 15 mg Oral pain reliever Menthol 2.6 mg Oral pain reliever
Uses
Uses: temporarily relieves occasional minor irritation and pain associated with: sore throat sore mouth canker sores
Warnings
Methemoglobinemia warning Use of this product may cause methemoglobinemia, 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. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. Do not use for teething in children under 5 years of age Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens 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...
Stop use and ask a doctor if
Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops
If pregnant or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage.
Directions
adults and children 5 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 5 years of age: do not use
Inactive ingredients
D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose
Storage
Other information store at 20-25°C (68-77°F) protect contents from humidity
Other information
1-866-682-4639

Label version 12, effective 12 May 2026. Retrieved from the openFDA drug label API on 4 September 2026. Read the full label on DailyMed.

Packages

Package NDCDescriptionListed from
63824-732-162 BLISTER PACK in 1 CARTON (63824-732-16) / 8 LOZENGE in 1 BLISTER PACK15 July 2013

The package NDC adds a third segment to the product code, identifying the pack size. See how to read an NDC.

Cepacol Extra Strength Sore Throat honey lemon on Amazon

Affiliate links

Amazon listings matching this brand name. They are not this exact NDC: Amazon lists a brand and a pack size, not a product code, so check the Drug Facts panel on what arrives against the strengths above.

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Lozenges.com is a reference publication built from FDA product listings and drug labels. It is not medical advice, diagnosis or treatment, it does not recommend any product for any condition, and it is not a substitute for a pharmacist or a doctor.