Walgreens

Manufacturer
Walgreens | Lornamead Inc. | CSR Cosmetic Solutions
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 23:53:07

Label at a glance#

ProductWalgreens Severe Oral Pain Reliever
Active ingredientBENZOCAINE
Label structure10 sections

Storage and handling

Other information do not purchase if package has been opened store at 20 - 25 C (68-77F) close cap tightly after use to avoid evaporation avoid contact with eyes avoid contact with clothing and household furniture surfaces to avoid possible staining this is a personal care item, and should be used by one individual only

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzocaine 20.0% (w/w)

OTC - PURPOSE SECTION

Purpose

Oral anesthetic/analgesic

INDICATIONS & USAGE SECTION

Use

for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums

WARNINGS SECTION

Warnings

For oral use only
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 - WHEN USING SECTION

When using this product

  • do not use for more than 7 days unless told to do so by a dentist or doctor If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or, if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • to assure formation of long lasting film coating, dry affected area and apply medication undiluted with applicator.
  • allow a few seconds for coating to form.
  • use up to 4 times daily, or as directed by a dentist or doctor.
  • children 12 years of age should be supervised in the use of this product.
  • children under 2 years of age: ask a dentist or doctor

STORAGE AND HANDLING SECTION

Other information

  • do not purchase if package has been opened
  • store at 20 - 25 C (68-77F)
  • close cap tightly after use to avoid evaporation
  • avoid contact with eyes
  • avoid contact with clothing and household furniture surfaces to avoid possible staining
  • this is a personal care item, and should be used by one individual only

INACTIVE INGREDIENT SECTION

Inactive ingredients

Benzyl Alcohol, Cetylpyridinium Chloride, Compound Benzoin Tincture, Dimethyl Isosorbide, Ethylcellulose, Flavor, Octylacrylamideacrylates/butylaminoethyl/methacrylate Copolymer, Oleth-10, PEG-6, Propylene Glycol, Ricinus Communis (Castor)
Seed Oil, SD Alcohol 38B, Sucralose, Tannic Acid.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com

MADE IN CANADA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Well at Walgreens

PROFESSIONAL STRENGTH

Mouth Sore Relief

Benzocaine 20% / Oral Anesthetic Liquid

0.5 FL OZ (14.7 mL)

blisterblister

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN10
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD10
308657benzocaine 20 % Mucous Membrane Topical SolutionSY10

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
0363-5335-512025-01-30C16284748780-12cef2736-81c3-d83d-e063-dadaa90ab31fWalgreens Professional Str Mouth Sore Relief Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5335-51WalgreensSevere Oral Pain Reliever1 in 1 BLISTER PACKLIQUID110
0363-5335-51WalgreensSevere Oral Pain Reliever14.17 g in 1 BOTTLE, WITH APPLICATORLIQUID14.1710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5335WALGREENS SEVERE ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [WALGREENS]10Legacy NDC, 2 package rows20230112_4fa350ce-720e-4949-8376-e90f0a0f2d66.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW51
BENZOCAINEACTIVE MOIETYU3RSY48JW51
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
BENZOININACTIVE INGREDIENTL7J6A1NE811
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49P1
DIMETHYL ISOSORBIDEINACTIVE INGREDIENTSA6A6V432S1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4B1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
OLETH-10INACTIVE INGREDIENTJD797EF70J1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQ1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
RICINUS COMMUNIS SEEDINACTIVE INGREDIENT7EK4SFN1TX1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
TANNIC ACIDINACTIVE INGREDIENT28F9E0DJY61
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-53350363-5335-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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 5 · 272 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQOINTMENT / TOPICAL1114 mgExact identifier — unii candidate
13 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BSYSTEM / TOPICAL10 mgExact identifier — unii candidate
14 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / SUBCUTANEOUS225 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / DENTALNAExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AAEROSOL, METERED / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / OPHTHALMIC1.5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SOFT TISSUE23 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3APOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASUSPENSION / ORAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRAMUSCULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii candidate
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / RECTAL124 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii candidate
22 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQCREAM / TOPICAL20 mgExact identifier — unii candidate
13 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRALESIONAL20 mgExact identifier — unii candidate
50 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BCAPSULE, EXTENDED RELEASE / ORAL153 mgExact identifier — unii candidate
14 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / VAGINAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACONCENTRATE / ORAL0.05 mg/5mlExact identifier — unii candidate
24 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
f1ffc068-9953-5382-e053-2995a90a1cd14fa350ce-720e-4949-8376-e90f0a0f2d662023-01-11WarningsExact identifier
spl id: f1ffc068-9953-5382-e053-2995a90a1cd1
spl set id: 4fa350ce-720e-4949-8376-e90f0a0f2d66

Reported adverse events (FAERS/openFDA)#

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