Throat Relief Lozenges
- Manufacturer
- BestCo Inc.
- Effective date
- 2012-07-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:17:13
Label at a glance#
Contacts and useful links#
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
Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a dentist or doctor right away. Do not use more than 2 days or give to children under 5 years of age unless directed by a doctor.
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 - 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 conatct 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, ask a doctor.
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? Call 1-800-245-2898, Monday thorugh Friday, 9AM - 4PM EST
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52642-017-09 | 2022-07-07 | C162847 | 48780-1 | 9d75b9d0-5545-f424-e053-dadaa90a57ce | Benzocaine 15 mg Menthol 3.6 mg |
| 52642-017-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5545-f424-e053-dadaa90a57ce | Benzocaine 15 mg Menthol 3.6 mg |
Products#
Every source-derived product name is available through these pages.
- Throat Relief Lozenges
- Benzocaine
- MENTHOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 52642-017 | 52642-017-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| WATER | 059QF0KO0R | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e33d76f2-f535-3478-e053-2995a90ac970 | 4bf3a064-6999-3d59-e054-00144ff8d46c | 2022-07-07 | Warnings | 4bf3a064-6999-3d59-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
