FDA.reportPublic FDA data

Equate Oral Pain Relief

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2020-08-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:25:02

Label at a glance#

ProductEquate Oral Pain Relief
Active ingredientBENZOCAINE
Label structure10 sections

Indications and uses

temporary relief of occasional minor irritation, pain and sore mouth

Dosage and administration

do not use tube if it is cut prior to opening cut open tip of tube on score mark use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel apply to affected area up to four times daily or as directed by a dentist or physician Adults and children 2 years of age and older: Apply to affected area Children under 12 years of age should be supervised in the use of this product Chil...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral Pain Reliever

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of occasional minor irritation, pain and sore mouth

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • more than directed
  • for more than 7 days unless told to do so by a dentist or doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

  • do not use tube if it is cut prior to opening
  • cut open tip of tube on score mark
  • use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
  • apply to affected area up to four times daily or as directed by a dentist or physician
  • Adults and children 2 years of age and older: Apply to affected area
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: Consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at a controlled room temperature 59°-86°F (15°-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carboer, D&C Yellow No10, FD&C Blue No1, FD&C Red No40, Flavor, Glycerin, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin

Principal Display Panel – 0.33oz Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11527-081-28

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20% NET WT. 0.33 OZ (9.35g)

Principal Display Panel – 0.33oz Carton LabelPrincipal Display Panel – 0.33oz Carton Label

Principal Display Panel – 0.33oz Carton Label
Principal Display Panel – 0.33oz Carton Label

Principal Display Panel – 0.33oz Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11527-081-28

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20%

The Adult Medicine for Toothache

Fast Toothache Pain Reliever

NET WT. 0.33 OZ (9.35g)

Principal Display Panel – 0.33oz Tube LabelPrincipal Display Panel – 0.33oz Tube Label

Principal Display Panel – 0.33oz Tube Label
Principal Display Panel – 0.33oz Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN2
238910benzocaine 0.2 MG/MG Oral GelSCD2
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11527-081-282022-01-28C16284748780-1d6a99b39-e000-a426-e053-dadaa90af4c253cbac1e-0382-4e03-80fb-f13bcae2b3dd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-081-28Equate Oral Pain Relief1 in 1 CARTONGEL12
11527-081-28Equate Oral Pain Relief9.35 g in 1 TUBEGEL9.352

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-081EQUATE ORAL PAIN RELIEF (BENZOCAINE) GEL [SHEFFIELD PHARMACEUTICALS LLC]2Legacy NDC, 2 package rows20200819_53cbac1e-0382-4e03-80fb-f13bcae2b3dd.zip

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
11527-08111527-081-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER 934Z135WT9208IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
Saccharin SodiumSB8ZUX40TYIACT
METHYLPARABENA2I8C7HI9TIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

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
1d3bffdc-28d0-4a4b-a5fe-76fec10ab7f853cbac1e-0382-4e03-80fb-f13bcae2b3dd2020-08-18WarningsExact identifier
spl id: 1d3bffdc-28d0-4a4b-a5fe-76fec10ab7f8
spl set id: 53cbac1e-0382-4e03-80fb-f13bcae2b3dd

Reported adverse events (FAERS/openFDA)#

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