FDA.reportPublic FDA data

Family Wellness Original Redness Relief Eye Drops

Manufacturer
Family Dollar Services, Inc. | KC Pharmaceuticals, Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:30:57

Label at a glance#

ProductFamily Wellness Original Redness Relief Eye Drops
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline HCl 0.05%

Purpose

OTC - PURPOSE SECTION

Redness reliever

Use

INDICATIONS & USAGE SECTION

  • relieves redness of the eye due to minor eye irritations

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

Other information

OTHER SAFETY INFORMATION

store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-527-4276

Family Wellness Original Redness Relief Eye Drops 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Family Wellness Original Redness Relief Eye Drops 15mLFamily Wellness Original Redness Relief Eye Drops 15mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN4
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD4
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSY4
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130032251912696GTIN-13: 0032251912696
EAN-13: 0032251912696
GTIN-12: 032251912696
UPC-A: 032251912696
GTIN storage (14 digits): 00032251912696		Family Wellness Original Redness Relief Eye Drops 15mL.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-907-01Family Wellness Original Redness Relief Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
55319-907-01Family Wellness Original Redness Relief Eye Drops1 in 1 BOXSOLUTION/ DROPS14

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-90755319-907-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
EDETATE DISODIUM7FLD91C86KIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM CHLORIDE451W47IQ8XIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
BORIC ACIDR57ZHV85D4IACT

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 Original Redness Relief Eye DropsTETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabf540a-8d5c-bb1c-e053-6394a90a75c22025-12-30WarningsExact identifier
ndc (package): 55319-907-01
ndc (product): 55319-907
ndc11 (package): 55319090701
spl id: 474528d1-7e7a-a211-e063-6294a90ae3c5
spl set id: fabf540a-8d5c-bb1c-e053-6394a90a75c2

Reported adverse events (FAERS/openFDA)#

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