FDA.reportPublic FDA data

GoodSense Oral Pain Relief Gel 0.5oz (191)

Manufacturer
Geiss, Destin and Dunn, Inc.
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:32:49

Label at a glance#

ProductGoodsense Oral Pain Relief
Active ingredientBENZOCAINE
Label structure13 sections

Storage and handling

Other information store at 20-25°C (68°-77°F) this preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist or doctor can be consulted do not use continuously

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                                   Purpose

Benzocaine 20%................................................. Oral pain reliever

OTC - PURPOSE SECTION

Uses

  • for the temporary relief of pain due to:
  • toothache
  • canker sores
  • gum pain
  • denture pain
  • cheek bites

WARNINGS SECTION

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have use this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Allergy Alert: do not use this product if your child has 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 directed by a doctor
  • for teething
  • in children under 2 years of age

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness does not go away
  • swelling, rash or fever develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

Directions

Adults and children 2 years of age and older

Remove cap and cut tip of tube. 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 doctor.

Children under 12 years of age.Should be supervised in the use of this product.
Children under 2 years of age.Do not use.

STORAGE AND HANDLING SECTION

Other information

  • store at 20-25°C (68°-77°F)
  • this preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist or doctor can be consulted
  • do not use continuously

INACTIVE INGREDIENT SECTION

Inactive ingredients: glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-888-645-8204 Monday - Friday 9AM-5PM (PST)

DOSAGE & ADMINISTRATION SECTION

Distributed by:

Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-645-8204

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

191191

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN10
238910benzocaine 0.2 MG/MG Oral GelSCD10
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY10

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130846036001914GTIN-13: 0846036001914
EAN-13: 0846036001914
GTIN-12: 846036001914
UPC-A: 846036001914
GTIN storage (14 digits): 00846036001914		191.1.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50804-191-102026-01-12C16284748780-1d6a99b39-ec78-a426-e053-dadaa90af4c2GoodSense Oral Pain Relief Gel 0.5oz (191)
50804-191-102025-01-30C16284748780-1d6a99b39-ec78-a426-e053-dadaa90af4c2GoodSense Oral Pain Relief Gel 0.5oz (191)
50804-191-102022-02-18C16284748780-1d6a99b39-ec78-a426-e053-dadaa90af4c2GoodSense Oral Pain Relief Gel 0.5oz (191)
50804-191-102022-01-28C16284748780-1d6a99b39-ec78-a426-e053-dadaa90af4c2GoodSense Oral Pain Relief Gel 0.5oz (191)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-191-10Goodsense Oral Pain Relief1 in 1 CARTONGEL110
50804-191-10Goodsense Oral Pain Relief14 g in 1 TUBEGEL1410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-191-10GM - Gram50804-1911d0f7c83-238c-4699-aa38-2c3274e5cf0812019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW51
BENZOCAINEACTIVE MOIETYU3RSY48JW51
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
MINTINACTIVE INGREDIENTFV98Z8GITP1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D951
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SORBITOLINACTIVE INGREDIENT506T60A25R1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50804-19150804-191-10

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
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
BENZOCAINEU3RSY48JW5ACTIB
MINTFV98Z8GITPIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML · Source PDF

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 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RLIQUID / TOPICAL1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii+route
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii+route
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii+route
16 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLOTION / TOPICAL10.7 %w/wExact identifier — unii+route
16 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95SOLUTION / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95OINTMENT / TOPICAL45 %w/wExact identifier — unii+route
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii+route
16 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / TOPICAL1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95SOLUTION / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95OINTMENT / TOPICAL45 %w/wExact identifier — unii+route
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii+route
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii+route
16 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii+route
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLOTION / TOPICAL10.7 %w/wExact identifier — unii+route
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii+route
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii+route
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii+route
16 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii+route
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii+route
16 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii+route+dosage form
2 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
Goodsense Oral Pain ReliefBENZOCAINEGeiss, Destin and Dunn, Inc.eb461b70-d10f-4e11-8374-e43713f3504d2026-01-12WarningsExact identifier
ndc (package): 50804-191-10
ndc (product): 50804-191
ndc11 (package): 50804019110
spl id: 483a8e8b-e815-3834-e063-6294a90a3225
spl set id: eb461b70-d10f-4e11-8374-e43713f3504d

Reported adverse events (FAERS/openFDA)#

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