Cēpacol

Manufacturer: Reckitt Benckiser LLC
Effective date: 2026-05-13
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 01:57:22

Label at a glance#

ProductCepacol Antibacterial

Active ingredientCETYLPYRIDINIUM CHLORIDE

Label structure11 sections

Indications and uses

helps prevent and reduce plaque that leads to: gingivitis, an early form of gum disease bleeding gums

Dosage and administration

adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use.

Storage and handling

this rinse is not intended to replace brushing or flossing store at room temperature 20-25°C (68-77°F) protect from humidity

Contacts and useful links#

PhoneLabel contact1-888-963-3382

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.05%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/Antiplaque

Uses

INDICATIONS & USAGE SECTION

helps prevent and reduce plaque that leads to:

gingivitis, an early form of gum disease
bleeding gums

Warnings

WARNINGS SECTION

Stop use and ask a dentist if

OTC - STOP USE SECTION

gingivitis, bleeding, or redness persists for more than 2 weeks
you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age.If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse
children 6 years to under 12 years of age: supervise use
children under 6 years of age: do not use.

Other Information

STORAGE AND HANDLING SECTION

this rinse is not intended to replace brushing or flossing
store at room temperature 20-25°C (68-77°F)
protect from humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, alcohol 14% v/v, glycerin, sodium phosphate dibasic, eucalyptus oil, polysorbate 80, methyl salicylate, cinnamon oil, peppermint oil, saccharin sodium, sodium phosphate monobasic anhydrous, menthol, edetate disodium, FD&C Yellow #5

Questions?

OTC - QUESTIONS SECTION

1-888-963-3382You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 710 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-790-80

Cēpacol^®

ANTIBACTERIAL*
MULTI-PROTECTION MOUTHWASH

CPC–Antigingivitis/Antiplaque Oral Rinse

*Kills Germs That Cause Bad Breath

Reduces Plaque
Freshens Breath

#1 BRAND IN HOSPITALS

TO OPEN:Squeeze both raised finger pads
on cap and continue to squeeze while turning.

TO CLOSE:Turn cap until it locks completely.

24 FL. OZ. (710 mL)

0336220
062111

PRINCIPAL DISPLAY PANEL - 710 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1251619	Cepacol Antibacterial 0.05 % Mouthwash	PSN	9
1251617	cetylpyridinium chloride 0.05 % Mouthwash	PSN	9
1251619	cetylpyridinium chloride 0.5 MG/ML Mouthwash [Cepacol Antibacterial Mouthwash]	SBD	9
1251617	cetylpyridinium chloride 0.5 MG/ML Mouthwash	SCD	9
1251619	Cepacol Antibacterial Mouthwash 0.5 MG/ML Mouthwash	SY	9
1251619	Cepacol Antibacterial Multi-Protection Mouthwash 0.5 MG/ML Mouthwash	SY	9
1251617	cetylpyridinium chloride 0.05 % Mouthwash	SY	9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63824-790-80	2022-06-23	C162847	48780-1	d6a99b39-85c2-a426-e053-dadaa90af4c2	Cēpacol ® ANTIBACTERIAL MULTI-PROTECTION MOUTHWASH
63824-790-80	2022-06-23	C162847	48780-1	d6a99b39-85c2-a426-e053-dadaa90af4c2	Cēpacol ® ANTIBACTERIAL MULTI-PROTECTION MOUTHWASH
63824-790-80	2022-01-28	C162847	48780-1	d6a99b39-85c2-a426-e053-dadaa90af4c2	Cēpacol ® ANTIBACTERIAL MULTI-PROTECTION MOUTHWASH
63824-790-80	2022-01-28	C162847	48780-1	d6a99b39-85c2-a426-e053-dadaa90af4c2	Cēpacol ® ANTIBACTERIAL MULTI-PROTECTION MOUTHWASH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63824-790-80	CepacolAntibacterial	710 mL in 1 BOTTLE	LIQUID	710		9
63824-790-80	CepacolAntibacterial	1 in 1 CARTON	LIQUID	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-790-80	ML - Milliliter	63824-790	0e050fc7-6f10-44dc-8ff9-076da5954e9c	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Cetylpyridinium chloride	ACTIVE INGREDIENT	D9OM4SK49P	3
Cetylpyridinium	ACTIVE MOIETY	CUB7JI0JV3	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	3
CINNAMON OIL	INACTIVE INGREDIENT	E5GY4I6YCZ	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	3
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	3
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	3
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	3
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	3
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Cepacol Antibacterial
Cetylpyridinium chloride
WATER
ALCOHOL
GLYCERIN
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
EUCALYPTUS OIL
POLYSORBATE 80
METHYL SALICYLATE
CINNAMON OIL
PEPPERMINT OIL
SACCHARIN SODIUM
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
MENTHOL, UNSPECIFIED FORM
EDETATE DISODIUM
FD&C YELLOW NO. 5
CETYLPYRIDINIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63824-790	63824-790-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
GLYCERIN	PDC6A3C0OX	IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	GR686LBA74	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
CINNAMON OIL	E5GY4I6YCZ	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
8	2025-12-23	monthly-update	2026-06-03 17:46:37

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 3 · 138 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	PASTE / ORAL		28 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route 52 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii+route 20 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED / ORAL	0.04 mg		Exact identifier — unii+route 52 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	CAPSULE / ORAL	16 mg		Exact identifier — unii+route 6 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii+route 20 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii+route 20 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii+dosage form 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii+route 52 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED / ORAL	0.04 mg		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii+route 52 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii+route 18 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / ORAL		526 mg	Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 18 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SYRUP / ORAL		70 mg	Exact identifier — unii+route 10 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	LOZENGE / ORAL		12 mg	Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 18 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	FILM, SOLUBLE / ORAL		9 mg	Exact identifier — unii+route 10 equally ranked IID candidates
CINNAMON OIL	CINNAMON OIL	E5GY4I6YCZ	SYRUP / ORAL	0.05 mg/5ml		Exact identifier — unii+route 8 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii+route 52 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	LOZENGE / ORAL		53 mg	Exact identifier — unii+route 6 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii+route 52 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	LOZENGE / ORAL		12 mg	Exact identifier — unii+route 20 equally ranked IID candidates
CINNAMON OIL	CINNAMON OIL	E5GY4I6YCZ	SUSPENSION / ORAL	0.2 mg/5ml		Exact identifier — unii+route 8 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SOLUTION / ORAL	40 mg/1ml		Exact identifier — unii+route 10 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CONCENTRATE / ORAL	17 mg/5ml		Exact identifier — unii+route 10 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	CONCENTRATE / ORAL	0.05 mg		Exact identifier — unii+route 20 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii+route 52 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LIQUID / ORAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	FILM, SOLUBLE / ORAL		9 mg	Exact identifier — unii+route 10 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii+route 52 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SUSPENSION / ORAL	100 mg/1ml		Exact identifier — unii+route 20 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii+route 52 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii+route 18 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii+route 18 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SOLUTION / ORAL		120 mg	Exact identifier — unii+route 12 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route 52 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	LOZENGE / ORAL		53 mg	Exact identifier — unii+route 6 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	TABLET, DELAYED RELEASE / ORAL	23.4 mg		Exact identifier — unii+route 12 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii+route 52 equally ranked IID candidates
CINNAMON OIL	CINNAMON OIL	E5GY4I6YCZ	ELIXIR / ORAL	0.58 mg/5ml		Exact identifier — unii+route 8 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii+dosage form 52 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SYRUP / ORAL		120 mg	Exact identifier — unii+route 20 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SOLUTION / ORAL		53 mg	Exact identifier — unii+route 20 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii+route 18 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER, FOR SUSPENSION / ORAL		396 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER / ORAL	66 mg		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii+route 52 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	CAPSULE / ORAL		60 mg	Exact identifier — unii+route 20 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 Antibacterial	CETYLPYRIDINIUM CHLORIDE	Reckitt Benckiser LLC	7c19eba6-3ebd-497f-9066-6152b72eafdd	2026-05-13	Warnings	Exact identifier ndc (package): 63824-790-80 ndc (product): 63824-790 ndc11 (package): 63824079080 spl id: 51b5db79-cd73-82f1-e063-6294a90ad768 spl set id: 7c19eba6-3ebd-497f-9066-6152b72eafdd

Reported adverse events (FAERS/openFDA)#

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