FDA.reportPublic FDA data

Cepacol

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-06-24
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:05:53

Label at a glance#

ProductCepacol Extra Strength Sore Throat honey lemon
Active ingredientBENZOCAINE, MENTHOL
Label structure10 sections

Indications and uses

Temporary relief of occasional sore throat sore mouth minor mouth irritation pain associated with canker sores

Dosage and administration

adults and children 5 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 5 years of age: do not use

Storage and handling

store between 20-25°C (68-77°F) protect contents from humidity

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each lozenge)Purposes
Benzocaine 15 mgOral pain reliever
Menthol 2.6 mgOral pain reliever

Uses

INDICATIONS & USAGE SECTION

Temporary relief of occasional

  • sore throat
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

Warnings

WARNINGS SECTION

METHEMOGLOBINEMIA WARNING

SPL UNCLASSIFIED SECTION

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. 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

OTC - DO NOT USE SECTION

  • Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or any other 'caine' anesthetics.

Sore throat warning

SPL UNCLASSIFIED SECTION

  • If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Stop use and ask a doctor or dentist if

OTC - STOP USE SECTION

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

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 this and all drugs out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Do not exceed recommended dosage.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 5 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
  • children under 5 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)
  • protect contents from humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Questions?

OTC - QUESTIONS SECTION

Call 1-866-682-4639

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England

CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
858664benzocaine 15 MG / menthol 2.6 MG Oral LozengePSN7
1235472Cepacol Sore Throat 15 MG / 2.6 MG Oral LozengePSN7
1235472benzocaine 15 MG / menthol 2.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]SBD7
858664benzocaine 15 MG / menthol 2.6 MG Oral LozengeSCD7
1235472Cepacol Sore Throat Pain Relief 15/2.6 (benzocaine / menthol) Oral LozengeSY7
1235472Cepacol Sore Throat Pain Relief 15/2.6 Oral LozengeSY7

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0732-12024-04-17C16284748780-11030e365-6017-111a-e063-dadaa90a10e2Cēpacol ® Extra Strength* Sore Throat honey lemon
17856-0732-12024-01-30C16284748780-11030e365-6017-111a-e063-dadaa90a10e2Cēpacol ® Extra Strength* Sore Throat honey lemon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0732-1Cepacol Extra Strength Sore Throat honey lemon50 in 1 BOXLOZENGE507
17856-0732-2Cepacol Extra Strength Sore Throat honey lemon1 in 1 POUCHLOZENGE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0732-1EA - Each17856-073234dca16d-b749-458e-a8b3-e810deab22dc12025-06-13
63824-732-16EA - Each63824-7327758e732-5bdc-4055-a3f5-57cf36bc3e5112014-04-03

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
17856-073217856-0732-2, 17856-0732-1
63824-732

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
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ISOMALTS870P55O2WIACT
MALTITOLD65DG142WKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SUCRALOSE96K6UQ3ZD4IACT
BENZOCAINEU3RSY48JW5ACTIB
MENTHOLL7T10EIP3AACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cepacol Extra Strength Sore Throat honey lemonBENZOCAINE AND MENTHOLReckitt Benckiser LLCd771095b-7de3-48f3-a125-8bc76e7d17782026-05-12WarningsExact identifier
ndc (product): 63824-732
Cepacol Extra Strength Sore Throat honey lemonBENZOCAINE AND MENTHOLATLANTIC BIOLOGICALS CORP.08160ced-e19b-443e-ab16-0d3e4ae8a8ab2025-06-24WarningsExact identifier
ndc (package): 17856-0732-2
ndc (package): 17856-0732-1
ndc (product): 17856-0732
ndc11 (package): 17856073202
ndc11 (package): 17856073201
spl id: 38526501-fa87-56f9-e063-6394a90a7159
spl set id: 08160ced-e19b-443e-ab16-0d3e4ae8a8ab

Reported adverse events (FAERS/openFDA)#

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