Orajel Instant Pain Relief

Manufacturer: Church Dwight Co., Inc.
Effective date: 2017-04-04
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:17:05

Label at a glance#

ProductOrajel Instant Pain Relief Severe

Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE, MENTHOL

Label structure12 sections

Contacts and useful links#

PhoneLabel contact1-800-952-5080

Websitewww.orajel.com

www.orajel.com

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Menthol 0.5%

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Oral Pain reliever

Antiseptic

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain due to toothaches
to help protect against infection in minor oral irritation

Warnings

WARNINGS SECTION

Allergy alert: do not use this product if you have a histoy of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

OTC - DO NOT USE SECTION

Do not use

more than directed
for more than 7 days unless directed by a physician or healthcare provider

OTC - ASK DOCTOR SECTION

Stop use and ask a physician if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN:

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions - cut open tip of tube on score mark

Adults and children 2 years of age and over - Apply a samll amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
Children under 12 years of age - Should be supervised in the use of this product
Children under 2 years of age - Ask a physicaian or healthcare provider

Other information

OTHER SAFETY INFORMATION

do not use if tube tip is cut prior to opening
this preparation is inteded for use in cases of toothache, only as a temporary expedient until a physician can be consulted
do not use continuously
Orajel Severe Pain Formula will stay in place for extended duration of relief
avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive ingredients

INACTIVE INGREDIENT SECTION

blue 1, cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORAL PAIN

Reliever for Toothache

Now with 3X More

Active Ingredients vs. Store Brand

Orajel™

Instant Pain Relief

SEVERE

Toothache & Gum Relief Plus

TRIPLE MEDICATED

20% Benzocaine to Relieve Oral Pain

Antiseptic to Help Prevent Infection

Menthol to Soothe

FAST-ACTING

GEL

Oral Pain Reliever/Antiseptic NET WT. 0.25 OZ (7.0g)

OJFC-32503-06

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1543432	benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG / menthol 0.005 MG/MG Oral Gel	benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG / menthol 0.005 MG/MG Oral Gel	SCD Active

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10237-752-25	2024-11-27	C162847	48780-1	9d75b9cf-fee4-f424-e053-dadaa90a57ce	Orajel SEVERE Toothache & Gum Relief Plus TRIPLE MEDICATED
10237-752-25	2020-01-31	C162847	48780-1	9d75b9cf-fee4-f424-e053-dadaa90a57ce	Orajel SEVERE Toothache & Gum Relief Plus TRIPLE MEDICATED

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	1
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	1
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PECTIN	INACTIVE INGREDIENT	89NA02M4RX	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
POLYETHYLENE GLYCOL 1000	INACTIVE INGREDIENT	U076Q6Q621	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1

Products#

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

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

Orajel Instant Pain Relief Severe
Benzocaine 20%, Menthol, Benzalkonium Chloride
CARBOXYMETHYLCELLULOSE SODIUM
FD&C BLUE NO. 1
GELATIN
SACCHARIN SODIUM
METHYL SALICYLATE
MINERAL OIL
PECTIN
PETROLATUM
POLYETHYLENE GLYCOL 1000
BENZOCAINE
BENZALKONIUM CHLORIDE
BENZALKONIUM
MENTHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10237-752	10237-752-25

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
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
MINERAL OIL	T5L8T28FGP	IACT
PECTIN	89NA02M4RX	IACT
PETROLATUM	4T6H12BN9U	IACT
POLYETHYLENE GLYCOL 1000	U076Q6Q621	IACT
BENZOCAINE	U3RSY48JW5	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB
MENTHOL	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 4 · 229 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
gelatin	GELATIN	2G86QN327L	TABLET / ORAL		46 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE, DENTIFRICE / DENTAL	1.2 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL		13 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET / SUBLINGUAL		19 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	CAPSULE, EXTENDED RELEASE / ORAL		1229 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	CAPSULE, COATED PELLETS / ORAL	65 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / RECTAL	0.01 %w/v		Exact identifier — unii candidate 37 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION / INTRAVENOUS	20 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	LOZENGE / ORAL		53 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		25 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000	POLYETHYLENE GLYCOL 1000	U076Q6Q621	SOLUTION / ORAL	1000 mg/5ml		Exact identifier — unii candidate 9 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET / ORAL		280 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	GUM, CHEWING / BUCCAL		102 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRAVITREAL	0.5 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ENTERAL		2920 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000	POLYETHYLENE GLYCOL 1000	U076Q6Q621	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		25 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / ORAL		3480 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	ELIXIR / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	SYSTEM / TOPICAL		1050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM, SOLUBLE / BUCCAL		47 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	SYRUP / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, EXTENDED RELEASE / ORAL		933 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE / ORAL	160 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	CAPSULE, COATED / ORAL		288 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION/ DROPS / ORAL	12.85 mg/2.5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, DELAYED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / SOFT TISSUE		15 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	AEROSOL, FOAM / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRA-ARTICULAR		30 mg	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
27e77f85-141f-186e-e063-6394a90a7538			c2205d76-3f62-4a36-95c1-bb3e37235744	2024-11-27	Warnings	Exact identifier spl set id: c2205d76-3f62-4a36-95c1-bb3e37235744

Reported adverse events (FAERS/openFDA)#

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