Mixed Berry Sore Throat Lozenges

The listing

NDC product code

36800-836 (labeller 36800, product 836)

Labeller

Topco Associates

Brand name

Mixed Berry Sore Throat Lozenges

Generic name

Benzocaine

Dosage form

Lozenge

Route

oral

Marketing category

OTC MONOGRAPH DRUG M012

Marketing start

3 August 2018

Listing expires

31 December 2026

Pharmacologic class

Standardized Chemical Allergen [EPC]

RxNorm concept

1039251

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 purposeCough suppressantOral anesthetic

Stated useSore throatCoughSore mouth, gums and canker soresCommon cold symptoms

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) Benzocaine 7.5 mg Dextromethorphan hydrobromide 5 mg

Purpose

Oral Pain Reliever Cough Suppressant

Uses

temporarily relieves these symptoms: occasional minor mouth irritation, sore mouth and sore throat cough due to minor throat and bronichial irritation as may occur with the common cold

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 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. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens, see your dentist or doctor promptly. 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.

Ask a doctor before use

persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

Stop use and ask doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling develops cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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.

Directions

adults and children 12 years and older - Allow 2 lozenges to dissolve slowly in mouth, one at a time; may be repeated every 4 hours, not to exceed 12 lozenges in 24 hours, or as directed by a doctor children 6 to 12 years - take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor children under 6 years of age - do not use

Inactive ingredients

Acesulfame potassium, corn starch, corn syrup, FD&C blue no. 1, FD&C red no. 40, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.

Other information

Or to report an adverse event call 1-888-423-0139

Label version 7, effective 20 December 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

6 other listings state exactly the same active ingredient at exactly the same strength in the same dosage form, across 6 different labellers. 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 36800-836
• DailyMed label, set id 7a00c771-9231-e877-e053-2a91aa0ac96e
• How Lozenges builds these pages