Anesthetic Lozenges Honey Lime Flavors

Manufacturer
PRASON FOODS
Effective date
2023-05-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:52

Label at a glance#

ProductAnesthetic Lozenges Honey Lime Flavors
Active ingredientBENZOCAINE, MENTHOL
Label structure8 sections

Indications and uses

Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine   15 mg

Menthol        2.6 mg

Purpose

OTC - PURPOSE SECTION

Oral anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth.

Warning

WARNINGS SECTION

Methemoglobinemia warning
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduced 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, grey, or blue colored skin (Cyanosis)
  • Headache
  • Rapid heart ache
  • Shortness of breath
  • Dizziness or light headedness
  • 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 persist or worsens, see your dentist or doctor promptly.

Do not use

  • For teething
  • In children under 5 years of age

Stop use and ask doctor if

  • Sore mouth symptoms do not improve in 7 days.


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


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

Allergy alert : Do not use this product if you have a history of allergy to local anesthetic such as procaine, butacaine, benzocaine, or other "caine" anesthetics

Directions

DOSAGE & ADMINISTRATION SECTION

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 Information

SPL UNCLASSIFIED SECTION

  • Store at room temperature
  • Protect from moisture.

TEMPER EVIDENT PACKAGING. DO NOT USE IF OUTER BOX OR BLISTER IS OPENED OR DAMAGED.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame k, Citric acid, Honey lime flavor, Liquid glucose, Sucrose, Tartaric acid, Tartrazine and Water

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
858664benzocaine 15 MG / menthol 2.6 MG Oral LozengePSN1
858664benzocaine 15 MG / menthol 2.6 MG Oral LozengeSCD1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83348-002-012024-07-30C16284748780-11030e365-55c3-111a-e063-dadaa90a10e2fb997cec-3025-4ca4-bd9a-b0331b1a6a2a
83348-002-012024-01-30C16284748780-11030e365-55c3-111a-e063-dadaa90a10e2fb997cec-3025-4ca4-bd9a-b0331b1a6a2a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83348-002-01Anesthetic Lozenges Honey Lime Flavors10 in 1 CARTONLOZENGE101
83348-002-01Anesthetic Lozenges Honey Lime Flavors9 in 1 BLISTER PACKLOZENGE91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83348-002ANESTHETIC LOZENGES HONEY LIME FLAVORS (BENZOCAINE,MENTHOL) LOZENGE [PRASON FOODS]12 package rows20230504_fb997cec-3025-4ca4-bd9a-b0331b1a6a2a.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83348-00283348-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
fab61465-dfeb-0498-e053-6294a90a9aecfb997cec-3025-4ca4-bd9a-b0331b1a6a2a2023-05-02WarningsExact identifier
spl id: fab61465-dfeb-0498-e053-6294a90a9aec
spl set id: fb997cec-3025-4ca4-bd9a-b0331b1a6a2a

Reported adverse events (FAERS/openFDA)#

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