Cēpacol

Manufacturer: Reckitt Benckiser LLC
Effective date: 2026-05-12
Label type: HUMAN OTC DRUG LABEL
Version: 11
Source: full-release
Hydrated at: 2026-06-01 01:56:58

Label at a glance#

ProductCepacol Extra Strength Sore Throat cherry

Active ingredientBENZOCAINE, MENTHOL, UNSPECIFIED FORM

Label structure10 sections

Indications and uses

USES temporarily relieves occasional minor irritation and pain associated with: sore throat sore mouth 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 at 20-25°C (68-77°F) protect contents from humidity

Contacts and useful links#

PhoneLabel contact1-866-682-4639

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 mg	Oral pain reliever
Menthol 3.6 mg	Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

USES

temporarily relieves occasional minor irritation and pain associated with:

sore throat
sore mouth
canker sores

Warnings

WARNINGS SECTION

Methemoglobinemia warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or 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, swelling, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

for teething
in children under 5 years of age

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 out of 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 at 20-25°C (68-77°F)
protect contents from humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red no. 33, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Questions?

OTC - QUESTIONS SECTION

1-866-682-4639

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-713-16

Cēpacol _®
EXTRA STRENGTH

#1
DOCTOR
RECOMMENDED ^†

SORE THROAT
Benzocaine 15 mg • Menthol 3.6 mg | Oral Pain Relievers

Relieves Sore Throat Pain
Fast Acting
Maximum Numbing*

16 Lozenges cherry flavor
*based on amount of benzocaine per dose

Label

label 2

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1235477	CEPACOL SORE THROAT PAIN RELIEF (Oral Lozenge)	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]	SBD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
824574	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge	PSN	11
1235477	Cepacol Sore Throat 15 MG / 3.6 MG Oral Lozenge	PSN	11
1235477	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]	SBD	11
824574	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge	SCD	11
1235477	Cepacol Sore Throat Pain Relief 15/3.6 (benzocaine / menthol) Oral Lozenge	SY	11
1235477	Cepacol Sore Throat Pain Relief 15/3.6 Oral Lozenge	SY	11

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0363824710167	GTIN-13: 0363824710167 EAN-13: 0363824710167 GTIN-12: 363824710167 UPC-A: 363824710167 GTIN storage (14 digits): 00363824710167	Cepacol Label 1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63824-713-04	CepacolExtra Strength Sore Throat cherry	4 in 1 BLISTER PACK	LOZENGE	4	11
63824-713-04	CepacolExtra Strength Sore Throat cherry	1 in 1 CARTON	LOZENGE	1	11
63824-713-16	CepacolExtra Strength Sore Throat cherry	8 in 1 BLISTER PACK	LOZENGE	8	11
63824-713-16	CepacolExtra Strength Sore Throat cherry	2 in 1 CARTON	LOZENGE	2	11
63824-713-94	CepacolExtra Strength Sore Throat cherry	1 in 1 CARTON	LOZENGE	1	11
63824-713-94	CepacolExtra Strength Sore Throat cherry	4 in 1 BLISTER PACK	LOZENGE	4	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-713-16	EA - Each	63824-713	01e4f83d-bb43-40b3-a104-54915296c781	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	3
Menthol, Unspecified Form	ACTIVE INGREDIENT	L7T10EIP3A	3
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	3
Menthol, Unspecified Form	ACTIVE MOIETY	L7T10EIP3A	3
D&C red no. 33	INACTIVE INGREDIENT	9DBA0SBB0L	3
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	3
isomalt	INACTIVE INGREDIENT	S870P55O2W	3
maltitol	INACTIVE INGREDIENT	D65DG142WK	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	3
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	3
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	3
water	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

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

Cepacol Extra Strength Sore Throat cherry
Benzocaine and Menthol
D&C RED NO. 33
FD&C RED NO. 40
ISOMALT
MALTITOL
PROPYLENE GLYCOL
WATER
SODIUM BICARBONATE
SUCRALOSE
BENZOCAINE
MENTHOL, UNSPECIFIED FORM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63824-713	63824-713-16, 63824-713-94, 63824-713-04

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
Name	UNII	Kind
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
ISOMALT	S870P55O2W	IACT
MALTITOL	D65DG142WK	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
BENZOCAINE	U3RSY48JW5	ACTIB
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 260 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii+route 88 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 80 equally ranked IID candidates
maltitol	MALTITOL	D65DG142WK	SOLUTION / ORAL		9000 mg	Exact identifier — unii+route 20 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route 88 equally ranked IID candidates
D&C red no. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE, LIQUID FILLED / ORAL	0.01 mg		Exact identifier — unii+route 48 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 88 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
maltitol	MALTITOL	D65DG142WK	CAPSULE / ORAL		155 mg	Exact identifier — unii+route 20 equally ranked IID candidates
D&C red no. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii+route 88 equally ranked IID candidates
isomalt	ISOMALT	S870P55O2W	TROCHE / ORAL	1718.71 mg		Exact identifier — unii+route 16 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 88 equally ranked IID candidates
D&C red no. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET / ORAL	0.24 mg		Exact identifier — unii+route 48 equally ranked IID candidates
sodium bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	LOZENGE / ORAL		100 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route 88 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii+route 88 equally ranked IID candidates
D&C red no. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
isomalt	ISOMALT	S870P55O2W	TABLET, CHEWABLE / ORAL		630 mg	Exact identifier — unii+route 16 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii+route 88 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii+route 88 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii+route 80 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii+route 80 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
D&C red no. 33	D&C RED NO. 33	9DBA0SBB0L	SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii+route 88 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 80 equally ranked IID candidates
isomalt	ISOMALT	S870P55O2W	TROCHE / ORAL	1718.71 mg		Exact identifier — unii+route 16 equally ranked IID candidates
maltitol	MALTITOL	D65DG142WK	SUSPENSION / ORAL	39600 mg/120ml		Exact identifier — unii+route 20 equally ranked IID candidates
maltitol	MALTITOL	D65DG142WK	FILM, SOLUBLE / ORAL		44 mg	Exact identifier — unii+route 20 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii+route 88 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 80 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii+route 80 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii+route 80 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 88 equally ranked IID candidates
D&C red no. 33	D&C RED NO. 33	9DBA0SBB0L	ELIXIR / ORAL	27.5 mg/5ml		Exact identifier — unii+route 48 equally ranked IID candidates
maltitol	MALTITOL	D65DG142WK	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii+route 20 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii+route 88 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii+route 88 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii+route 88 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii+route 88 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cepacol Extra Strength Sore Throat cherry	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	2026-05-12	Warnings	Exact identifier ndc (package): 63824-713-94 ndc (package): 63824-713-04 ndc (package): 63824-713-16 ndc (product): 63824-713 ndc11 (package): 63824071394 ndc11 (package): 63824071304 ndc11 (package): 63824071316 spl id: 51a69c7a-3f79-01bc-e063-6394a90adcaa spl set id: 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0

Reported adverse events (FAERS/openFDA)#

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

Cēpacol

Label at a glance#

Indications and uses

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Uses

Warnings

Methemoglobinemia warning

Allergy alert

Sore throat warning

Do not use

Stop use and ask a doctor or dentist if

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

Product Linked Resources#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#