Family Wellness Pain Relief

Manufacturer
FAMILY DOLLAR (Family Wellness) | Sheffield Pharmaceuticals LLC
Effective date
2026-01-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:34:29

Label at a glance#

ProductFamily Wellness Pain Relief
Active ingredientBENZOCAINE
Label structure11 sections

Indications and uses

temporary relief of occasional minor irritation, pain and sore mouth

Dosage and administration

do not use tube if it is cut prior to opening cut open tip of tube on score mark use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel apply to affected area up to four times daily or as directed by a dentist or physician Adults and children 2 years of age and older: Apply to affected area Children under 12 years of age should be supervised in the use of this product Chil...

Label contents#

Full prescribing information#

Active Ingredient 

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral Pain Reliever

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of occasional minor irritation, pain and sore mouth

Warnings 

WARNINGS SECTION

Methemoglobinema Warning:Use of this product may cause Methemoglobinema, a serious condition that must be treated promptly becasue it reduces the amount of oxygem carried in the blood. This can occur even if you have used this product before. Stop use and seek immeditate medical attention if you or a child in yuor 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.

Do not use

OTC - DO NOT USE SECTION

more than directed
for more than 7 days unless told to do so by a dentist or doctor

Stop use and ask a Doctor if

OTC - STOP USE SECTION

swelling, rash or fever develops
irritation, pain, or redness persists or worsens

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use tube if it is cut prior to opening
  • cut open tip of tube on score mark
  • use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
  • apply to affected area up to four times daily or as directed by a dentist or physician
  • Adults and children 2 years of age and older: Apply to affected area
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: Consult a doctor

Inactive Ingredients 

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carbomer, D&C Yellow No 10, FD&C Blue No 1, FD&C Red No 40, Flavor, Glycerin, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin

Other information 

OTHER SAFETY INFORMATION

store at a controlled room temperature 68°- 77°F (20°-25°C)

Principal Display Panel 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55319-157-33

Family Wellness 

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20% NET WT. 0.33 OZ (9.35g)

FW_OralAnesGel_0.33oz_CartonFW_OralAnesGel_0.33oz_Carton

FW_OralAnesGel_0.33oz_TubeFW_OralAnesGel_0.33oz_Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN2
238910benzocaine 0.2 MG/MG Oral GelSCD2
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY2

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-130032251911750GTIN-13: 0032251911750
EAN-13: 0032251911750
GTIN-12: 032251911750
UPC-A: 032251911750
GTIN storage (14 digits): 00032251911750
5416515_996960_FW_OralAnesGel_0.33oz_Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-157-33Family Wellness Pain Relief1 in 1 CARTONGEL12
55319-157-33Family Wellness Pain Relief9.35 g in 1 TUBEGEL9.352

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-15755319-157-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
Family Wellness Pain ReliefBENZOCAINE 20%FAMILY DOLLAR (Family Wellness)92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea2026-01-21WarningsExact identifier
ndc (package): 55319-157-33
ndc (product): 55319-157
ndc11 (package): 55319015733
spl id: 48e8a690-d306-c44e-e063-6294a90af535
spl set id: 92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea

Reported adverse events (FAERS/openFDA)#

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