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 19 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
application number: M018
Capasil Pain RelievingMENTHOL, METHYL SALICYLATEPureTek Corporationb1a8e78c-57f0-1f3e-e053-2995a90acbd52024-10-01WarningsExact identifier
application number: M018
Mencylate Pain RelievingMENTHOL, METHYL SALICYLATEPureTek Corporationf824de86-9492-2e6b-e053-6294a90a6f2a2024-10-01WarningsExact identifier
application number: M018
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
application number: M018
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporatedcc3d5bc8-9d3c-4c65-9e43-707a2db4081a2024-09-25WarningsExact identifier
application number: M018
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated93fafa27-5031-4d95-b4b8-5574b7204ae22024-09-25WarningsExact identifier
application number: M018
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated454f337e-d897-46de-ab05-1c543a33061c2024-09-25WarningsExact identifier
application number: M018
PURPOSEOCTINOXATE, OCTISALATE AND OXYBENZONEBausch & Lomb Incorporateda1e14135-b8da-4cee-8c5b-1893572f4de42024-09-25WarningsExact identifier
application number: M018
Soothe Night TimeWHITE PETROLATUM MINERAL OILBausch & Lomb Incorporated638d3c3f-9960-43da-956e-0e28c77f533e2024-09-24WarningsExact identifier
application number: M018
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated10fcf407-6eaf-4730-9ed0-9b7715cf57012024-09-20WarningsExact identifier
application number: M018
Soothe XP Preservative FreeLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedb254d885-6d49-4c95-b6be-cfdad49c85e62024-09-20WarningsExact identifier
application number: M018
blink gel tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated6f7e06c3-204d-459a-af8f-c46be9ad0e8d2024-09-20WarningsExact identifier
application number: M018
Soothe XPLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedc0f053da-8d22-433e-a36e-79cf15ad387f2024-09-20WarningsExact identifier
application number: M018
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
application number: M018
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
application number: M018
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
application number: M018
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
application number: M018
Eyes Alive LubricatingCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDRIVIERA PHARMA INCb6966691-6884-438c-9f89-5924089226e12024-05-31WarningsExact identifier
application number: M018
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact 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