Oral Analgesic

Manufacturer: Meijer Distribution, Inc. | Church & Dwight Co., Inc.
Effective date: 2010-05-13
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:53:11

Label at a glance#

ProductOral Analgesic Maximum Strength

Active ingredientBenzocaine

Label structure5 sections

Indications and uses

Uses temporarily relieves pain associated with: toothache minor dental procedures Warnings Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor Stop use and ask a physician if swellin...

Dosage and administration

Directions do not use if tube is cut prior to opening; cut open tip of tube on score mark Adults and children 2 years of age and over Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or physician Children under 12 years of age ...

Contacts and useful links#

PhoneLabel contact1-800-952-5080

Websitewww.orajel.com

www.orajel.com

Label contents#

Full prescribing information#

Uses

WARNINGS SECTION

Uses temporarily relieves pain associated with:

toothache minor dental procedures

Warnings

Allergy alert: do not use this product if you have a history 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 told to do so by a dentist or doctor

OTC - ASK DOCTOR SECTION

Stop use and ask a physician if swelling, rash or fever develops; irritation, pain or redness persists or worsens

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children:

in case of overdose, get medical help or contact a Poison Control Center right away.

Directions

OTC - ASK DOCTOR SECTION

Directions

do not use if tube is cut prior to opening; cut open tip of tube on score mark

Adults and children 2 years of age and over Apply a small amount of product to the cavity and around gum surrounding the teeth.
Use up to 4 times daily or as directed by a dentist or physician

Children under 12 years of age Should be supervised in the use of this product

Children under 2 years of age Ask a dentist or doctor

Other information This preparation is intended for use in case of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients flavor, polyethylene glycol, sodium saccharin, sorbic acid

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orajel gel

Instant Pain Relief

for TOOTHACHE

MAXIMUM STRENGTH

NE WT 0.42 OZ (11.9 g) ORAL PAIN RELIEVER BENZOCAINE 20%

carton image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
41250-701-25	2025-12-01	C162847	48780-1	9d75b9d1-0078-f424-e053-dadaa90a57ce	Drug Facts
41250-701-25	2020-01-31	C162847	48780-1	9d75b9d1-0078-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-701	ORAL ANALGESIC MAXIMUM STRENGTH (ORAL PAIN RELIEVER) GEL [MEIJER DISTRIBUTION, INC.]	3	Legacy NDC	20100519_5372eea1-afd5-4bde-8d76-f6b0aaffc199.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	3
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	3
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	3
sorbic acid	INACTIVE INGREDIENT	X045WJ989B	3

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Oral Analgesic Maximum Strength
Oral Pain Reliever
Benzocaine
polyethylene glycol
SACCHARIN SODIUM
sorbic acid

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41250-701	41250-701-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Benzocaine	U3RSY48JW5	ACTIB
polyethylene glycol	3WJQ0SDW1A	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
sorbic acid	X045WJ989B	IACT

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 · 53 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 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
sorbic acid	SORBIC ACID	X045WJ989B	TABLET / ORAL		10 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	SUSPENSION / ORAL		40 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		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
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	SOLUTION/ DROPS / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	SOLUTION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	EMULSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	GEL / TOPICAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 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	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 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
sorbic acid	SORBIC ACID	X045WJ989B	TABLET, FILM COATED / ORAL		5 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	SOLUTION / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	TABLET, DELAYED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	TABLET / SUBLINGUAL	0.16 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 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
437b75f4-466c-ce98-e063-6394a90ab4f6			5372eea1-afd5-4bde-8d76-f6b0aaffc199	2025-11-13	Warnings	Exact identifier spl set id: 5372eea1-afd5-4bde-8d76-f6b0aaffc199

Reported adverse events (FAERS/openFDA)#

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