Mixed Berry Sore Throat Lozenges

Manufacturer
Topco Associates | Bestco Inc.
Effective date
2025-12-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:27:37

Label at a glance#

ProductMixed Berry Sore Throat Lozenges
Active ingredientBENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each lozenge)

Benzocaine 7.5 mg

Dextromethorphan hydrobromide 5 mg

OTC - PURPOSE SECTION

Purposes

Oral Pain Reliever

Cough Suppressant

INDICATIONS & USAGE SECTION

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 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)
  • 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.

OTC - DO NOT USE SECTION

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • for teething
  • in children under 2 years of age

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

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

OTC - STOP USE SECTION

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.

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 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

OTHER SAFETY INFORMATION

Other information

  • store at room temperature
  • protect from moisture

INACTIVE INGREDIENT SECTION

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.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare Mixed Berry Benx-Dex 18ctTopCare Mixed Berry Benx-Dex 18ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039251dextromethorphan HBr 5 MG / benzocaine 7.5 MG Oral LozengePSN7
1039251benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral LozengeSCD7

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800418400GTIN-13: 0036800418400
EAN-13: 0036800418400
GTIN-12: 036800418400
UPC-A: 036800418400
GTIN storage (14 digits): 00036800418400
TopCare Mixed Berry Benz-Dex 18ct NDC 36800-836-18.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-836-18Mixed Berry Sore Throat Lozenges18 in 1 BLISTER PACKLOZENGE187

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-83636800-836-18

Ingredients#

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

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

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
Mixed Berry Sore Throat LozengesBENZOCAINETopco Associates7a00c771-9231-e877-e053-2a91aa0ac96e2025-12-20WarningsExact identifier
ndc (package): 36800-836-18
ndc (product): 36800-836
ndc11 (package): 36800083618
spl id: 466f3fd5-c9e4-619b-e063-6294a90a5ec3
spl set id: 7a00c771-9231-e877-e053-2a91aa0ac96e

Reported adverse events (FAERS/openFDA)#

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