Meijer Maximum Strength Oral Pain Relief

Manufacturer
MEIJER DISTRIBUTION INC
Effective date
2016-12-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:09

Label at a glance#

ProductMeijer Maximum Strength Oral Pain Relief
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE
Label structure11 sections

Storage and handling

Other information do not use if tube tip is cut prior to opening this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted do not use continuously avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                           Purpose

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

Benzalkonium chloride 0.1%............Antiseptic

OTC - PURPOSE SECTION

Use

  • for the temporary relief of pain due to toothaches
  • to help protect against infection in minor oral irritation

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 - DO NOT USE SECTION

Do not use

  • more than directed
  • for more than 7 days unless directed by a physician or healthcare provider

OTC - STOP USE 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
  • allergic reaction occurs

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.

INDICATIONS & USAGE SECTION

Directions

  • cut open tip of tube on score mark
     Adults and children 2 years of age and over                                                                                                                               Apply a small amount of product to the cavity around gum surrounding the teeth.
     Children under 12 years of age Should be supervised in the use of this product
     Children under 2 years of age Ask a physician or healthcare provider

STORAGE AND HANDLING SECTION

Other information

  • do not use if tube tip is cut prior to opening
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
  • do not use continuously
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595155benzocaine 20 % / benzalkonium chloride 0.1 % Oral GelPSN1
1595155benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral GelSCD1
1595155benzalkonium chloride 0.1 % / benzocaine 20 % Oral GelSY1

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-130713733380782GTIN-13: 0713733380782
EAN-13: 0713733380782
GTIN-12: 713733380782
UPC-A: 713733380782
GTIN storage (14 digits): 00713733380782
PA 38078.01 PL MEI Orajel .42oz.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41250-782-422020-01-31C16284748780-19d75b9d0-c7c9-f424-e053-dadaa90a57cedb38f8be-56e1-4e5d-a565-dee523dd1a8b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-782-42Meijer Maximum Strength Oral Pain Relief1 in 1 BOXGEL11
41250-782-42Meijer Maximum Strength Oral Pain Relief11.9 g in 1 TUBEGEL11.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-782MEIJER MAXIMUM STRENGTH ORAL PAIN RELIEF (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [MEIJER DISTRIBUTION INC]1Legacy NDC, 2 package rows20161208_db38f8be-56e1-4e5d-a565-dee523dd1a8b.zip

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
41250-78241250-782-42

Ingredients#

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

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

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
611508fa-29c3-435d-b8c4-b2c4bfb0ae8edb38f8be-56e1-4e5d-a565-dee523dd1a8b2016-12-08WarningsExact identifier
spl id: 611508fa-29c3-435d-b8c4-b2c4bfb0ae8e
spl set id: db38f8be-56e1-4e5d-a565-dee523dd1a8b

Reported adverse events (FAERS/openFDA)#

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