FDA.reportPublic FDA data

Medics Choice Eye Drops Original Redness Reliever

Product NDC
55651-005
11-digit product format
556510005
Labeler code
55651
Product ID
55651-005_4748ccb8-2816-8c8c-e063-6294a90a908c
Type
HUMAN OTC DRUG
Nonproprietary name
tetrahydrozoline hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
KC Pharmaceuticals, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-08-28
Substance
TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Medics Choice Eye Drops Original Redness Reliever
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0YZT43HS7DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1052943Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7beAvailable on FDA.report

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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DEYE DROPS REGULAR (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077EYE DROPS REGULAR (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7EYE DROPS REGULAR (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4EYE DROPS REGULAR (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEYE DROPS REGULAR (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOEYE DROPS REGULAR (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEYE DROPS REGULAR (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0REYE DROPS REGULAR (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55651-005MEDICS CHOICE EYE DROPS ORIGINAL REDNESS RELIEVER (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20240110_e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be.zip

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 3 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
application number: M018
Nano Eye Drop SerumWATER. SORBITOL.1.2-HEXANEDIOL GLYCERIN HYALURONATESODIUM.Shenzhen Yiyang Zhiting Technology Co., Ltd539567d6-488a-9b01-e063-6394a90abece2026-06-06WarningsExact identifier
application number: M018
REFRESH CELLUVISCCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.b32ed9e8-d091-4f16-b416-5a62cdfee49a2026-06-05WarningsExact identifier
application number: M018
VitaPhyte Redness Reliever Lubricant Eye DropsREDNESS RELIEVER LUBRICANT EYE DROPSGuangzhou Liyan Cosmetics Technology Co., Ltd.53d4e9b0-c9a0-797a-e063-6294a90ad0cf2026-06-04WarningsExact identifier
application number: M018
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
application number: M018
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
application number: M018
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
application number: M018
Blink Triple Care Preservative FreePOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated65e67990-78b7-4ce9-963b-6bed3a6bed072026-05-27WarningsExact identifier
application number: M018
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
application number: M018
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
application number: M018
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporatedf1d07347-086f-43b2-aa5f-910764fc666e2026-05-13WarningsExact identifier
application number: M018
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
application number: M018
Sodium Hyaluronate Eye DropsSODIUM HYALURONATEGuangzhou Hechuang Commercial Service Co.,Ltd.5187d136-15c6-517b-e063-6294a90a811d2026-05-11WarningsExact identifier
application number: M018
Splash TearsHYPROMELLOSELABORATORIOS SOPHIA, S.A. DE C.V.a58a8478-9cc5-aa39-e053-2995a90a347d2026-05-08WarningsExact identifier
application number: M018
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
application number: M018
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
application number: M018
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNe42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be4
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDe42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be4
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSYe42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be4
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSYe42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55651-005-01556510005011 BOTTLE, DROPPER in 1 CARTON (55651-005-01) / 15 mL in 1 BOTTLE, DROPPER2003-08-280000-00-00NoNoCurrent