FDA.reportPublic FDA data

Medics Choice Eye Drops Original Redness Reliever

Manufacturer
KC Pharmaceuticals, Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:30:45

Label at a glance#

ProductMedics Choice Eye Drops Original Redness Reliever
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Tetrahydrozoline HCl 0.05%

OTC - PURPOSE SECTION

Purpose

Tetrahydrozoline HCl.................Redness reliever

INDICATIONS & USAGE SECTION

Use

■ relieves redness of the eye due to minor eye irritations

WARNINGS SECTION

Warnings

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have narrow angle glaucoma

OTC - WHEN USING SECTION

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 lens before using

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

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

OTHER SAFETY INFORMATION

Other information

store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

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-130095072005510GTIN-13: 0095072005510
EAN-13: 0095072005510
GTIN-12: 095072005510
UPC-A: 095072005510
GTIN storage (14 digits): 00095072005510		MCReg_Orig.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55651-005-01Medics Choice Eye Drops Original Redness Reliever15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
55651-005-01Medics Choice Eye Drops Original Redness Reliever1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7D1
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y0771
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W71
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D41
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QO1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
55651-00555651-005-01

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
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM CHLORIDE451W47IQ8XIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Medics Choice Eye Drops Original Redness RelieverTETRAHYDROZOLINE HYDROCHLORIDEKC Pharmaceuticals, Inc.e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be2025-12-30WarningsExact identifier
ndc (package): 55651-005-01
ndc (product): 55651-005
ndc11 (package): 55651000501
spl id: 4748ccb8-2816-8c8c-e063-6294a90a908c
spl set id: e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be

Reported adverse events (FAERS/openFDA)#

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