Orajel Instant Pain Relief

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

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 ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Menthol 0.25%

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
allergic reaction occurs

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

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

Long-Lasting

CREAM

Oral Pain Reliever/Antiseptic NET WT 0.33 OZ (9.4g)

OJFC-32501-06_CREAM.jpg

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
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 · 14 matching rows.

Orajel Instant Pain Relief Severe
Benzocaine 20%, Menthol, Benzalkonium Chloride
CARBOXYMETHYLCELLULOSE SODIUM
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
10237-747	10237-747-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	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 · 192 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SYRUP / ORAL	26.5 mg		Exact identifier — unii candidate 44 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
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, DELAYED RELEASE / ORAL		280 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
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		25 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000	POLYETHYLENE GLYCOL 1000	U076Q6Q621	GEL / TRANSDERMAL	0.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 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
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / SOFT TISSUE		15 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	POWDER / RESPIRATORY (INHALATION)	100 mg		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	LOTION / TOPICAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	POWDER / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GEL / DENTAL	0.4 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET / PERIODONTAL	3.44 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	CAPSULE / ORAL	16 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM / BUCCAL		18 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION / INTRAVENOUS	20 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE / ORAL	NA		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
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	CAPSULE / ORAL		10932 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED / ORAL	50 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000	POLYETHYLENE GLYCOL 1000	U076Q6Q621	TABLET, FILM COATED / ORAL	1.52 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii candidate 44 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	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SUSPENSION / INTRAMUSCULAR	0.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYL SALICYLATE	METHYL SALICYLATE	LAV5U5022Y	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	SOLUTION / ORAL	34.8 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
gelatin	GELATIN	2G86QN327L	INJECTION / INTRAMUSCULAR	16 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRALESIONAL		15 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PECTIN	PECTIN	89NA02M4RX	SPRAY / NASAL	10 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 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
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRAMUSCULAR		30 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / ORAL		120 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 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
4c6ea515-ad26-3d66-e054-00144ff8d46c			024a2222-07ac-4b70-a05e-3c977a14b694	2017-04-05	Warnings	Exact identifier spl id: 4c6ea515-ad26-3d66-e054-00144ff8d46c spl set id: 024a2222-07ac-4b70-a05e-3c977a14b694

Reported adverse events (FAERS/openFDA)#

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