Cherry Sore Throat Lozenge

Manufacturer
TopCo | Bestco Inc.
Effective date
2025-12-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:27:37

Label at a glance#

ProductCherry Sore Throat Lozenge
Active ingredientMENTHOL, BENZOCAINE
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each lozenge)

Benzocaine 15 mg

Menthol 3.6 mg

OTC - PURPOSE SECTION

Purpose

Oral anesthetic

Oral anesthetic

INDICATIONS & USAGE SECTION

Uses temporarily relieves these symptoms:

occasional minor irritation, pain, sore mouth and sore throat

WARNINGS SECTION

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)
  • hearache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Sore throat warning: If sore throat is severe, persistent 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 persist 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.

OTC - DO NOT USE SECTION

Do not use

  • for teething
  • in children under 2 years of age

OTC - STOP USE SECTION

Stop use and ask doctor if

sore throat is severe or irritation, pain, or redness persists or worsens

sore mouth symptoms do not improve in 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 5 years and older - allow 1 lozenge to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.

children under 5 years - do not use

OTHER SAFETY INFORMATION

Other information

store at room temperature

protect from moisture

INACTIVE INGREDIENT SECTION

Inactive ingredients: Corn starch, FD&C Red #40, glucose syrup, glycerin, medium chain triglycerides, natural & artificial flavors, propylene glycol, soybean oil, sucrose and water.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare Cherry Benzocaine 18ctTopCare Cherry Benzocaine 18ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
824574benzocaine 15 MG / menthol 3.6 MG Oral LozengePSN8
824574benzocaine 15 MG / menthol 3.6 MG Oral LozengeSCD8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800405806GTIN-13: 0036800405806
EAN-13: 0036800405806
GTIN-12: 036800405806
UPC-A: 036800405806
GTIN storage (14 digits): 00036800405806
TopCare Cherry Benzocaine 18ct NDC 36800-832-18.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-832-18Cherry Sore Throat Lozenge18 in 1 BLISTER PACKLOZENGE188

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-83236800-832-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
BENZOCAINEU3RSY48JW5ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cherry Sore Throat LozengeBENZOCAINETopCo60b876e7-c642-5ce8-e053-2a91aa0abd6e2025-12-20WarningsExact identifier
ndc (package): 36800-832-18
ndc (product): 36800-832
ndc11 (package): 36800083218
spl id: 466eef0f-4edb-a0a8-e063-6394a90a4ad1
spl set id: 60b876e7-c642-5ce8-e053-2a91aa0abd6e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.