Cēpacol ® SORE THROAT SPRAY

Manufacturer: RB Health (US) LLC
Effective date: 2023-09-27
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 21:25:39

Label at a glance#

ProductCepacol Sore Throat

Active ingredientDYCLONINE HYDROCHLORIDE, GLYCERIN

Label structure10 sections

Indications and uses

for temporary relief of: occasional minor irritation, pain, sore mouth, and sore throat pain associated with canker sores minor discomfort and protection of irritated areas in sore mouth and sore throat

Dosage and administration

adults and children 4 years of age and older: Spray 4 times into throat or affected area. Gargle, swish around or allow to remain in place at least 1 minute and then spit out. Repeat up to 4 times daily or as directed by a dentist or doctor. Children 4 to under 12 years of age should be supervised in the use of this product. children under 4 years of age: do not use

Storage and handling

store at room temperature 20-25°C (68-77°F) do not freeze

Contacts and useful links#

PhoneLabel contact1-888-963-3382

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purpose
Dyclonine Hydrochloride 0.1%	Oral pain reliever
Glycerin 33%	Oral demulcent

Uses

INDICATIONS & USAGE SECTION

for temporary relief of:

occasional minor irritation, pain, sore mouth, and sore throat
pain associated with canker sores
minor discomfort and protection of irritated areas in sore mouth and sore throat

Warnings

WARNINGS SECTION

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.

Stop use and ask a doctor or dentist if

OTC - STOP USE SECTION

sore mouth symptoms do not improve in 7 days

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 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.

OTC - WHEN USING SECTION

When using this producttry to avoid swallowing spray.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 4 years of age and older: Spray 4 times into throat or affected area. Gargle, swish around or allow to remain in place at least 1 minute and then spit out. Repeat up to 4 times daily or as directed by a dentist or doctor. Children 4 to under 12 years of age should be supervised in the use of this product.
children under 4 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

store at room temperature 20-25°C (68-77°F)
do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetylpyridinium chloride, D&C red #33, deionized water, FD&C yellow #6, flavor, menthol, phosphoric acid, poloxamer 338, potassium sorbate, sodium phosphate dibasic, sorbitol

Questions?

OTC - QUESTIONS SECTION

1-888-963-3382

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-781-74

Cēpacol^®

SORE THROAT SPRAY

Dyclonine HCl 0.1%• Oral Pain Reliever
Glycerin 33% • Oral Demulcent

Fast Sore Throat Relief

Instant Acting
Coats & Soothes

4 FL OZ (118 mL)

SUGAR FREE
cherry

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63824-781-74	2023-09-27	C162847	48780-1	d6a99b39-eaf7-a426-e053-dadaa90af4c2	Cēpacol ® SORE THROAT SPRAY
63824-781-74	2022-01-28	C162847	48780-1	d6a99b39-eaf7-a426-e053-dadaa90af4c2	Cēpacol ® SORE THROAT SPRAY

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Dyclonine Hydrochloride	ACTIVE INGREDIENT	ZEC193879Q	1
Glycerin	ACTIVE INGREDIENT	PDC6A3C0OX	1
Dyclonine	ACTIVE MOIETY	078A24Q30O	1
Glycerin	ACTIVE MOIETY	PDC6A3C0OX	1
cetylpyridinium chloride	INACTIVE INGREDIENT	D9OM4SK49P	1
D&C red No. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
FD&C yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	1
menthol	INACTIVE INGREDIENT	L7T10EIP3A	1
phosphoric acid	INACTIVE INGREDIENT	E4GA8884NN	1
poloxamer 338	INACTIVE INGREDIENT	F75JV2T505	1
potassium sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	1
sodium phosphate, dibasic	INACTIVE INGREDIENT	GR686LBA74	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Cepacol Sore Throat
Dyclonine Hydrochloride and Glycerin
CETYLPYRIDINIUM CHLORIDE
D&C RED NO. 33
WATER
FD&C YELLOW NO. 6
MENTHOL, UNSPECIFIED FORM
PHOSPHORIC ACID
POLOXAMER 338
POTASSIUM SORBATE
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
SORBITOL
DYCLONINE HYDROCHLORIDE
DYCLONINE
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63824-781	63824-781-74

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
WATER	059QF0KO0R	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
POLOXAMER 338	F75JV2T505	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	GR686LBA74	IACT
SORBITOL	506T60A25R	IACT
DYCLONINE HYDROCHLORIDE	ZEC193879Q	ACTIB
GLYCERIN	PDC6A3C0OX	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 4 · 182 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
phosphoric acid	PHOSPHORIC ACID	E4GA8884NN	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
cetylpyridinium chloride	CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	SOLUTION / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 5 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 candidate 14 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
phosphoric acid	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
phosphoric acid	PHOSPHORIC ACID	E4GA8884NN	LOTION, AUGMENTED / TOPICAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CONCENTRATE / ORAL	17 mg/5ml		Exact identifier — unii candidate 14 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
D&C red No. 33	D&C RED NO. 33	9DBA0SBB0L	SUSPENSION / ORAL	0.13 mg/5ml		Exact identifier — unii candidate 14 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	DROPS / NASAL	40.32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
phosphoric acid	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / ORAL		19 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, FILM COATED / ORAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	FILM / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
D&C red No. 33	D&C RED NO. 33	9DBA0SBB0L	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, DELAYED RELEASE / ORAL	0.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
phosphoric acid	PHOSPHORIC ACID	E4GA8884NN	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOAP / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
D&C red No. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
cetylpyridinium chloride	CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	AEROSOL, METERED / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
cetylpyridinium chloride	CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	SYRUP / ORAL	4 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / SUBCUTANEOUS		14 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	CREAM / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION/ DROPS / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
FD&C yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / ORAL	75.3 mg/15ml		Exact identifier — unii candidate 34 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
phosphoric acid	PHOSPHORIC ACID	E4GA8884NN	TABLET, EXTENDED RELEASE / ORAL	0.19 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
phosphoric acid	PHOSPHORIC ACID	E4GA8884NN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
phosphoric acid	PHOSPHORIC ACID	E4GA8884NN	AEROSOL, FOAM / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
phosphoric acid	PHOSPHORIC ACID	E4GA8884NN	CREAM / VAGINAL	0.56 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii candidate 19 equally ranked IID candidates
phosphoric acid	PHOSPHORIC ACID	E4GA8884NN	TABLET / ORAL	0.04 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
D&C red No. 33	D&C RED NO. 33	9DBA0SBB0L	SHAMPOO / TOPICAL	NA		Exact identifier — unii candidate 14 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
0650e5e8-122a-6c92-e063-6394a90ac9c0			af621c32-ec5d-4f5a-ae19-6ff260675ac8	2023-09-27	Warnings	Exact identifier spl id: 0650e5e8-122a-6c92-e063-6394a90ac9c0 spl set id: af621c32-ec5d-4f5a-ae19-6ff260675ac8

Reported adverse events (FAERS/openFDA)#

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