Orajel Antiseptic Rinse

Manufacturer: Church & Dwight Canada Corp. | Church & Dwight Co., Inc.
Effective date: 2014-10-23
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:34:41

Label at a glance#

ProductOrajel Antiseptic Rinse For All Mouth Sores

Active ingredientHYDROGEN PEROXIDE, MENTHOL

Label structure11 sections

Contacts and useful links#

Websitewww.orajel.com

www.orajel.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Hydrogen peroxide 1.5%

Menthol 0.1%

OTC - PURPOSE SECTION

Purpose

Oral debriding agent/Oral antiseptic

Oral pain reliever

INDICATIONS & USAGE SECTION

Uses

first aid to help reduce bacteria in minor oral wounds
for temporary pain relief and
use in cleansing minor wounds or minor gum inflammation resulting from:
minor dental procedures
accidental injury
orthodontic appliances
canker sores
dentures
other irritations of the mouth and gums

Aids in the removal of

phlegm
mucus
other secretions associated with occasional sore mouth

WARNINGS SECTION

Warnings

Do not use this product for more than 7 days unless directed by a dentist or healthcare provider

When using this product

do not swallow
do not exceed recommended dosage

OTC - STOP USE SECTION

Stop Use and see your physician promptly if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions

remove imprinted safety seal from bottle cap
to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed.

Adults and children

2 years of age and older

Swish one-half capful (2 tesapoons=10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider

Children under 12 years of age

Should be supervised in the use of this product

Children under 2 years of age

Consult a dentist or healthcare provider

OTHER SAFETY INFORMATION

Other Information

cap tightly
keep away from heat or direct sunlight
do not use if safety seal is broken or missing

INACTIVE INGREDIENT SECTION

Inactive ingredients alcohol (4.1% by volume), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

OTC - QUESTIONS SECTION

Questions or comments call us at 1–800–952–5080 M–F 9am–5pm ET or visit our website at www.orajel.com

Orajel Alcohol Free Antiseptic Rinse

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PAIN RELIEVER

BRAND FOR ADULTS

NOW WITH PAIN RELIEF!

Orajel

Antiseptic Rinse

FOR ALL MOUTH SORES

Canker Sores Cheek Bites Gum Irritation

Irritatrion from Dentures or Braces

Promotes Healing

Kills Bacteria

Provides Pain Relief

FRESH MINT

ORAL DEBRIDING AGENT / ANTISEPTIC RINSE / PAIN RELIEVER

16 FL OZ (473.2 mL)

Front Label OJLBF-32499-04.jpg OJLBF-32499-04.jpg

Back Label OJLBB-32499-04.jpg OJLBB-32499-04.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62864-760-16	2024-11-21	C162847	48780-1	9d75b9d0-e974-f424-e053-dadaa90a57ce	DRUG FACTS Orajel Antiseptic Rinse for All Mouth Sores
62864-760-16	2020-01-31	C162847	48780-1	9d75b9d0-e974-f424-e053-dadaa90a57ce	DRUG FACTS Orajel Antiseptic Rinse for All Mouth Sores

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROGEN PEROXIDE	ACTIVE INGREDIENT	BBX060AN9V	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	1
HYDROGEN PEROXIDE	ACTIVE MOIETY	BBX060AN9V	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	1
POLOXAMER 338	INACTIVE INGREDIENT	F75JV2T505	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	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 · 14 matching rows.

Orajel Antiseptic Rinse For All Mouth Sores
Hydrogen Peroxide 1.5%, Menthol 0.1%
FD&C BLUE NO. 1
EDETATE DISODIUM
METHYL SALICYLATE
PHOSPHORIC ACID
POLOXAMER 338
POLYSORBATE 20
SACCHARIN SODIUM
SORBITOL
WATER
ALCOHOL
HYDROGEN PEROXIDE
MENTHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62864-760	62864-760-16

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
FD&C BLUE NO. 1	H3R47K3TBD	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
POLOXAMER 338	F75JV2T505	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
HYDROGEN PEROXIDE	BBX060AN9V	ACTIB
MENTHOL	L7T10EIP3A	ACTIB

Source Document#

Source XML · Source PDF

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 6 · 315 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CAPSULE / ORAL		563 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SPRAY, METERED / NASAL		40 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	TABLET / ORAL	10 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	DOUCHE / VAGINAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	INJECTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 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
2518283e-587d-b054-e063-6394a90afb1c			0618c1d8-5c8f-1e88-e054-00144ff8d46c	2024-10-22	Warnings	Exact identifier spl set id: 0618c1d8-5c8f-1e88-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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