FDA.reportPublic FDA data

Walgreens

Manufacturer
Walgreens | Lornamead Products | HK KOLMAR CANADA, INC
Effective date
2025-08-12
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:10:09

Label at a glance#

ProductWalgreens Maximum Strength
Active ingredientBENZOCAINE
Label structure10 sections

Storage and handling

Other information do not use if package has been opened tore at 20-25°C (68-77°F)

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

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves pain associated with the following mouth irritations:

  • toothache
  • sore gums
  • canker sores
  • braces
  • minor dental procedures

WARNINGS SECTION

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 - WHEN USING SECTION

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage
  • do not use more than directed for more than 7 days unless directed by a dentist or doctor.

OTC - STOP USE SECTION

Stop use and ask a doctor or dentist if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

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

Adults and children 2 years of age and older:

  • apply to affect4ed area using applicator tip
  • 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: ask a dentist or doctor.

STORAGE AND HANDLING SECTION

Other information

  • do not use if package has been opened
  • tore at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

SPL UNCLASSIFIED SECTION

Questions or comments? 1-800-925-4733

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD. DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

www.walgreens.com

MADE IN CANADA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Card R5Card R5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN14
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD14
308657benzocaine 20 % Mucous Membrane Topical SolutionSY14

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
0363-5820-482023-06-01C16284748780-1f386c649-fcd3-0266-e053-dadaa90a7c1a5820364 Walgreens Instant Oral Pain Relief Liquid
0363-5820-482023-01-30C16284748780-1f386c649-fcd3-0266-e053-dadaa90a7c1a5820364 Walgreens Instant Oral Pain Relief Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5820-48WalgreensMaximum Strength14.7 g in 1 BOTTLELIQUID14.714
0363-5820-48WalgreensMaximum Strength1 in 1 BLISTER PACKLIQUID114
0363-5820-58WalgreensMaximum Strength1 in 1 BLISTER PACKLIQUID114
0363-5820-58WalgreensMaximum Strength14.7 g in 1 BOTTLELIQUID14.714

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-58200363-5820-58, 0363-5820-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
FD&C RED NO. 40WZB9127XOAIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
METHYLPARABENA2I8C7HI9TIACT

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
Walgreens Maximum StrengthBENZOCAINEWalgreens8f24309d-d393-455a-a9a5-a55344adf36b2025-08-12WarningsExact identifier
ndc (package): 0363-5820-48
ndc (package): 0363-5820-58
ndc (product): 0363-5820
ndc11 (package): 00363582058
ndc11 (package): 00363582048
spl id: 3c30c27f-175d-9395-e063-6294a90a0a9a
spl set id: 8f24309d-d393-455a-a9a5-a55344adf36b

Reported adverse events (FAERS/openFDA)#

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