FDA.reportPublic FDA data

Original Redness Reliever

Manufacturer
KC Pharmaceuticals
Effective date
2025-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:28:40

Label at a glance#

ProductOriginal Redness Reliever
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Redness Reliever

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
TetrahydrozolineHCI0.05%

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
(1-800-222-1222) right away.

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS & USAGE SECTION

■ relieves redness of the eye due to minor eye irritations

WARNINGS SECTION

Warnings
For external use only
Ask a doctor before use if you have narrow angle glaucoma
When using this product
■ 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 lenses before using
Stop use and ask a doctor if 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
Hpregnant orbreast-feeding,askahealth professional before use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Redness RelieverOriginal Redness Reliever

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN1
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD1
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSY1
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130194346489848GTIN-13: 0194346489848
EAN-13: 0194346489848
GTIN-12: 194346489848
UPC-A: 194346489848
GTIN storage (14 digits): 00194346489848		Walmart_EDRG NDC 79903-363-01.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
55651-063-01Original Redness Reliever1 in 1 BOXSOLUTION/ DROPS11
55651-063-01Original Redness Reliever15 mL in 1 BOTTLESOLUTION/ DROPS151

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
55651-06355651-063-01

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
SODIUM CHLORIDE451W47IQ8XIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM BORATE91MBZ8H3QOIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
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
Original Redness RelieverTETRAHYDROLIZINE HCLKC Pharmaceuticals4683b850-b0fc-5093-e063-6294a90aef442025-12-21WarningsExact identifier
ndc (package): 55651-063-01
ndc (product): 55651-063
ndc11 (package): 55651006301
spl id: 4683b850-b0fd-5093-e063-6294a90aef44
spl set id: 4683b850-b0fc-5093-e063-6294a90aef44

Reported adverse events (FAERS/openFDA)#

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