FDA.reportPublic FDA data

Orajel Instant Pain Relief

Manufacturer
Church & Dwight Co., Inc. | Accupac
Effective date
2013-11-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:38:42

Label at a glance#

ProductOrajel Instant Pain Relief SEVERE
Active ingredientBENZOCAINE
Label structure13 sections

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain due to

  • toothaches
  • canker sores
  • minor injury of the mouth and gums
  • minor irritation of the mouth and gums caused by dentures

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

SPL UNCLASSIFIED SECTION

Flammable: keep away from fire or flame.  Avoid smoking during application and until this product has dried

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 product with cotton swab or finger 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 imprinted bottle seal is broken or missing 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (54.6% by volume), flavor, polyethylene glycol, red 40, sodium saccharin, water, yellow 5

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

Principal Display - OJFC-32531-03 #1 Oral Pain Reliever for Toothache                    Orajel Instant Pain Relief SEVERE Toothache & Oral Pain Relief 20% Benzocaine to Relieve Oral PainToothache        Canker SoresGum Pain          Denture PainCheek Bites...

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton imageCarton image

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW51
BENZOCAINEACTIVE MOIETYU3RSY48JW51
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M1
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q6211
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-75310237-753-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
ALCOHOL3K9958V90MIACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C RED NO. 40WZB9127XOAIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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 3 · 152 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MOINTMENT / TOPICAL0.01 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, CHEWABLE / ORAL4.5 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / BUCCAL0.4 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000POLYETHYLENE GLYCOL 1000U076Q6Q621CREAM / TOPICAL0.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MLIQUID / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSYRUP / ORAL0.1 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000POLYETHYLENE GLYCOL 1000U076Q6Q621GEL / TOPICAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MCAPSULE / ORAL652 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / BUCCAL0.11 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MCAPSULE, EXTENDED RELEASE / ORAL0.26 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 1000POLYETHYLENE GLYCOL 1000U076Q6Q621AEROSOL, FOAM / TOPICALNAExact identifier — unii candidate
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / ORAL180 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RECTAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MCONCENTRATE / BUCCALNAExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / SUBLINGUAL0.11 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii candidate
28 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9cbba2f9-19b5-ed74-e053-2a95a90adb03707d27da-731c-4726-9c77-63fcc071d09d2020-01-22WarningsExact identifier
spl set id: 707d27da-731c-4726-9c77-63fcc071d09d

Reported adverse events (FAERS/openFDA)#

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