FDA.reportPublic FDA data

Family Dollar

Manufacturer
Family Dollar Services Inc. | Lornamead | CSR Cosmetic Solutions Inc.
Effective date
2023-06-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:55:14

Label at a glance#

ProductFamily Dollar Oral Pain Relief
Active ingredientBENZOCAINE
Label structure10 sections

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzocaine 20% (W/W)

OTC - PURPOSE SECTION

Purpose

Oral anesthetic

INDICATIONS & USAGE SECTION

Use

Temporarily relieves pain associated with the following mouth and gum irritations:

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

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 used 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 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 told to do so by a dentist or doctor
  • for teething
  • in children under 2 years of age

OTC - STOP USE SECTION

Stop use and ask a doctor 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, 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 affected 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: do not use

STORAGE AND HANDLING SECTION

Other information

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

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

MADE IN CANADA

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

10611 MONROE RD.

MATTHEWS, NC 28105

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Card R2Card R2FAMILY WELLNESS

MAXIMUM STRENGTH

Oral Pain Relief

20% Benzocaine

Liquid Anesthetic

0.5 FL OZ (14.7 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN7
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD7
308657benzocaine 20 % Mucous Membrane Topical SolutionSY7

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
55319-388-822025-01-30C16284748780-12cef2736-6bab-d83d-e063-dadaa90ab31f5820388 Family Wellness Max Str Oral Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-388-82Family DollarOral Pain Relief14.7 g in 1 BOTTLELIQUID14.77
55319-388-82Family DollarOral Pain Relief1 in 1 CARTONLIQUID17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-388FAMILY DOLLAR ORAL PAIN RELIEF (BENZOCAINE) LIQUID [FAMILY DOLLAR SERVICES INC.]7Legacy NDC, 2 package rows20230615_ddd0a678-3cee-42a1-a34e-a870e2dd4a4f.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
55319-38855319-388-82

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

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
fe07ad15-d59e-237d-e053-6294a90a9776ddd0a678-3cee-42a1-a34e-a870e2dd4a4f2023-06-13WarningsExact identifier
spl id: fe07ad15-d59e-237d-e053-6294a90a9776
spl set id: ddd0a678-3cee-42a1-a34e-a870e2dd4a4f

Reported adverse events (FAERS/openFDA)#

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