FDA.reportPublic FDA data

Chloraseptic Warming Honey Lemon

Manufacturer
Prestige Brands Holdings, Inc.
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:12:36

Label at a glance#

ProductChloraseptic Warming Honey Lemon
Active ingredientBENZOCAINE
Label structure10 sections

Indications and uses

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

Dosage and administration

Adults and children 6 years of age and older : Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth. Children under 6 years:  Do not use.  

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each lozenge)

Benzocaine 15 mg

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

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. If a skin reaction occurs, stop use and seek medical help right away.

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 6 years of age unless directed by a doctor.

Do not use

OTC - DO NOT USE SECTION

  • for teething
  • in children under 6 years

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a dentist or doctor if

OTC - ASK DOCTOR SECTION

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years of age and older: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
  • Children under 6 years: Do not use.  

Other information

OTHER SAFETY INFORMATION

  • store between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • check expiration date before using 
  • contains FD&C yellow no. 5 (tartrazine) as a color additive

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn syrup, FD&C yellow no. 5, flavor, glycerin, honey, propylene glycol, soy lecithin, sucrose, water

Questions?

OTC - QUESTIONS SECTION

1-800-552-7932 Chloraseptic.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chloraseptic© 
warming
SORE THROAT
FAST ACTING
Numbs throat in seconds*
SAFE FOR THE FAMILY AGES 6+ EXTRA SOOTHING LIQUID CENTER
HONEY LEMON
18 LOZENGES

Chloraseptic© warming SORE THROAT FAST ACTING Numbs throat in seconds* SAFE FOR THE FAMILY AGES 6+ EXTRA SOOTHING LIQUID CENTER HONEY LEMON 18 LOZENGESChloraseptic© warming SORE THROAT FAST ACTING Numbs throat in seconds* SAFE FOR THE FAMILY AGES 6+ EXTRA SOOTHING LIQUID CENTER HONEY LEMON 18 LOZENGES

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199071benzocaine 15 MG Oral LozengePSN3
1245378Chloraseptic Warming Sore Throat 15 MG Oral LozengePSN3
1245378benzocaine 15 MG Oral Lozenge [Chloraseptic]SBD3
199071benzocaine 15 MG Oral LozengeSCD3
1245378Chloraseptic 15 MG Oral LozengeSY3
1245378Chloraseptic Warming Sore Throat 15 MG Oral LozengeSY3

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-019-02Chloraseptic Warming Honey Lemon18 in 1 CARTONLOZENGE183

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67172-01967172-019-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
CORN SYRUP9G5L16BK6NIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HONEYY9H1V576FHIACT
GLYCERINPDC6A3C0OXIACT

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
157527d6-1ad8-4d93-b557-ee9cf029a14dd3cd9ac7-58ff-4284-9b98-82d3fdda078d2025-09-08WarningsExact identifier
spl id: 157527d6-1ad8-4d93-b557-ee9cf029a14d
spl set id: d3cd9ac7-58ff-4284-9b98-82d3fdda078d

Reported adverse events (FAERS/openFDA)#

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