Cepacol Extra Strength Sore Throat honey lemon

The listing

NDC product code

17856-0732 (labeller 17856, product 0732)

Labeller

ATLANTIC BIOLOGICALS CORP.

Brand name

Cepacol Extra Strength Sore Throat honey lemon

Generic name

Benzocaine and Menthol

Dosage form

Lozenge

Route

oral

Marketing category

OTC MONOGRAPH DRUG M

Marketing start

15 July 2013

Listing expires

31 December 2026

Pharmacologic class

Standardized Chemical Allergen [EPC]

RxNorm concept

858664

Active ingredients

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 throatSore 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

Temporary relief of occasional sore throat sore mouth minor mouth irritation pain associated with canker sores

Warnings

METHEMOGLOBINEMIA WARNING Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. 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 any 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, nausea, or vomiting, consult a doctor promptly. 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 this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage.

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 this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 between 20-25°C (68-77°F) protect contents from humidity

Other information

Call 1-866-682-4639 You may also report side effects to this phone number.

Label version 7, effective 24 June 2025. Retrieved from the openFDA drug label API on 4 September 2026. Read the full label on DailyMed.

Packages

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

Identical on the active ingredient

One other listing states exactly the same active ingredient at exactly the same strength in the same dosage form. They are not necessarily the same product: inactive ingredients, flavour and pack size differ, and this site does not compare prices.

Sources for this page

• FDA National Drug Code Directory entry for 17856-0732
• DailyMed label, set id 08160ced-e19b-443e-ab16-0d3e4ae8a8ab
• How Lozenges builds these pages