FDA.reportPublic FDA data

CHLORASEPTIC

Manufacturer
Prestige Brands Holdings, Inc.
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:32:21

Label at a glance#

ProductCHLORASEPTIC
Active ingredientMENTHOL, BENZOCAINE
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 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 ingredients (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 6 mg

Menthol 10 mg

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

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 of age

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 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 15○ - 30○C (59○ - 86○F)
  • protect from moisture
  • check expiration date before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn syrup, FD&C red no. 40, FD&C yellow no. 6, flavor, glycerin, propylene glycol, soy lecithin, sucrose, water

Questions?

OTC - QUESTIONS SECTION

1-800-552-7932 or Chloraseptic.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chloraseptic®

Menthol | Benzocaine Oral Pain Reliever Lozenges

Citrus | 18 lozenges

Chloraseptic® Menthol | Benzocaine Oral Pain Reliever Lozenges Citrus | 18 lozengesChloraseptic® Menthol | Benzocaine Oral Pain Reliever Lozenges Citrus | 18 lozenges

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308668benzocaine 6 MG / menthol 10 MG Oral LozengePSN4
802559Chloraseptic Sore Throat 10 MG / 6 MG Oral LozengePSN4
802559benzocaine 6 MG / menthol 10 MG Oral Lozenge [Chloraseptic Sore Throat]SBD4
308668benzocaine 6 MG / menthol 10 MG Oral LozengeSCD4
802559Chloraseptic Sore Throat (benzocaine 6 MG / menthol 10 MG) Oral LozengeSY4
802559Chloraseptic Sore Throat Oral LozengeSY4

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
67172-022-18CHLORASEPTIC3 in 1 CARTONLOZENGE34
67172-022-18CHLORASEPTIC6 in 1 BLISTER PACKLOZENGE64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-022CHLORASEPTIC (MENTHOL AND BENZOCAINE) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]4Current NDC, Legacy NDC, 2 package rows20241101_d500f423-b9f2-4d98-8f2a-8bab7c05737c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67172-02267172-022-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
BENZOCAINEU3RSY48JW5ACTIB
CORN SYRUP9G5L16BK6NIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCROSEC151H8M554IACT
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
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.d500f423-b9f2-4d98-8f2a-8bab7c05737c2024-10-25WarningsExact identifier
ndc (package): 67172-022-18
ndc (product): 67172-022
ndc11 (package): 67172002218
spl id: 74db7012-7756-4fcf-8118-5e6a01b92267
spl set id: d500f423-b9f2-4d98-8f2a-8bab7c05737c

Reported adverse events (FAERS/openFDA)#

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