Orajel Antiseptic Rinse

Manufacturer: Church & Dwight Co., Inc. | Church & Dwight Canada Corp.
Effective date: 2025-12-12
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:28:12

Label at a glance#

ProductOrajel Antiseptic Rinse For All Mouth Sores

Active ingredientHYDROGEN PEROXIDE, MENTHOL, UNSPECIFIED FORM

Label structure9 sections

Contacts and useful links#

Websitewww.orajel.com

www.orajel.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 1.5%

Menthol 0.1%

OTC - PURPOSE SECTION

Oral debriding agent/Oral antiseptic

Oral pain reliever

INDICATIONS & USAGE SECTION

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

When using this productdo not swallow

do not exceed recommended dosage

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

Stop use and see your physician promptly ifswallowing, rash or fever develops; irritation, 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

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 commentscall us at 1–800–952–5080 M–F 9am–5pm ET or visit our website atwww.orajel.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORAL PAIN

RELIEVER BRAND

FOR ADULTS

With

PAIN RELIEF!

Orajel™

FOR ALL MOUTH SORES

ANTISEPTIC RINSE

Canker Sores Cheek Bites Gum Irritation

Irritation from Dentures or Braces

Promotes Healing

Kills Bacteria

Provides Pain Relief

SOOTHING

MINT

RINSE

ORAL DEBRIDING AGENT / ANTISEPTIC RINSE / PAIN RELIEVER

16 FL OZ (473.2 mL)

DA2011184_OJLBF-32499-06_72013522

10237-793 Back Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2584344	hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical Solution	PSN	5
2584344	hydrogen peroxide 15 MG/ML / menthol 1 MG/ML Mucous Membrane Topical Solution	SCD	5
2584344	hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical Solution	SY	5

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0310310324995	GTIN-13: 0310310324995 EAN-13: 0310310324995 GTIN-12: 310310324995 UPC-A: 310310324995 GTIN storage (14 digits): 00310310324995	10237-793 Back Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10237-760-16	2021-11-04	C162847	48780-1	9d75b9d0-0d7b-f424-e053-dadaa90a57ce	Orajel Antiseptic Rinse for All Mouth Sores
10237-760-16	2020-01-31	C162847	48780-1	9d75b9d0-0d7b-f424-e053-dadaa90a57ce	Orajel Antiseptic Rinse for All Mouth Sores

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10237-760-16	Orajel Antiseptic Rinse For All Mouth Sores	473.2 mL in 1 BOTTLE	LIQUID	473.2	5
10237-760-48	Orajel Antiseptic Rinse For All Mouth Sores	3 in 1 PACKAGE	LIQUID	3	5
10237-760-48	Orajel Antiseptic Rinse For All Mouth Sores	473.2 mL in 1 BOTTLE	LIQUID	473.2	5

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 and Menthol
FD&C BLUE NO. 1
EDETATE DISODIUM
METHYL SALICYLATE
PHOSPHORIC ACID
POLOXAMER 338
POLYSORBATE 20
SACCHARIN SODIUM
SORBITOL
WATER
ALCOHOL
HYDROGEN PEROXIDE
MENTHOL, UNSPECIFIED FORM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10237-760	10237-760-16, 10237-760-48

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, 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 1 · 57 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+route 18 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET / ORAL		17 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, EXTENDED RELEASE / ORAL	0.19 mg		Exact identifier — unii+route 15 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CAPSULE / ORAL		563 mg	Exact identifier — unii+route 18 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii+route 18 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	LOZENGE / ORAL		53 mg	Exact identifier — unii+route 9 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, EXTENDED RELEASE / ORAL	0.19 mg		Exact identifier — unii+route 15 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / ORAL		19 mg	Exact identifier — unii+route 15 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET, FILM COATED / ORAL	0.35 mg		Exact identifier — unii+route 18 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, EXTENDED RELEASE / ORAL	0.19 mg		Exact identifier — unii+route 15 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	LOZENGE / ORAL		53 mg	Exact identifier — unii+route 9 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii+route 18 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / ORAL		19 mg	Exact identifier — unii+route 15 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET / ORAL		17 mg	Exact identifier — unii+route 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	CAPSULE / ORAL	16 mg		Exact identifier — unii+route 9 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / ORAL		80 mg	Exact identifier — unii+route 18 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	TABLET / ORAL	10 mg		Exact identifier — unii+route 9 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii+route 15 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, ORALLY DISINTEGRATING / ORAL		4 mg	Exact identifier — unii+route 15 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii+route 18 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / ORAL		80 mg	Exact identifier — unii+route 18 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / ORAL		80 mg	Exact identifier — unii+route 18 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET, FILM COATED / ORAL	0.35 mg		Exact identifier — unii+route 18 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET / ORAL		17 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, ORALLY DISINTEGRATING / ORAL		4 mg	Exact identifier — unii+route 15 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CAPSULE / ORAL		563 mg	Exact identifier — unii+route 18 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii+route 18 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET / ORAL	0.04 mg		Exact identifier — unii+route 15 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, ORALLY DISINTEGRATING / ORAL		4 mg	Exact identifier — unii+route 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	TABLET / ORAL	10 mg		Exact identifier — unii+route 9 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	TABLET / ORAL	10 mg		Exact identifier — unii+route 9 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	CAPSULE / ORAL	16 mg		Exact identifier — unii+route 9 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii+route 15 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET, FILM COATED / ORAL	0.35 mg		Exact identifier — unii+route 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET / ORAL	0.04 mg		Exact identifier — unii+route 15 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	CAPSULE / ORAL	16 mg		Exact identifier — unii+route 9 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / ORAL		19 mg	Exact identifier — unii+route 15 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii+route 18 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii+route 15 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET / ORAL	0.04 mg		Exact identifier — unii+route 15 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii+route 18 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	LOZENGE / ORAL		53 mg	Exact identifier — unii+route 9 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route+dosage form 3 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
Orajel Antiseptic Rinse For All Mouth Sores	HYDROGEN PEROXIDE AND MENTHOL	Church & Dwight Co., Inc.	06188d36-0d60-6ae6-e054-00144ff8d46c	2025-12-12	Warnings	Exact identifier ndc (package): 10237-760-48 ndc (package): 10237-760-16 ndc (product): 10237-760 ndc11 (package): 10237076048 ndc11 (package): 10237076016 spl id: 45c2ec2f-1ee1-84f8-e063-6294a90ae393 spl set id: 06188d36-0d60-6ae6-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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