Topcare Maximum Redness Relief Eye Drops

Product NDC
36800-975
11-digit product format
368000975
Labeler code
36800
Product ID
36800-975_0cfa9846-2cd8-d0fc-e063-6394a90af06b
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, naphazoline hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Topco Assoc LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-04
Substance
GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Active strength
.5; .03 g/100mL; g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
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
Topcare Maximum Redness Relief Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN.5 g/100mL
NAPHAZOLINE HYDROCHLORIDE.03 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
MZ1131787DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1235200Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c6193a6-d824-1b27-e053-2995a90ab3cfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-975-01Topcare Maximum Redness Relief Eye Drops1 in 1 CARTONSOLUTION13
36800-975-01Topcare Maximum Redness Relief Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-975TOPCARE MAXIMUM REDNESS RELIEF EYE DROPS (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) SOLUTION [TOPCO ASSOC LLC]3Current NDC, Legacy NDC, 2 package rows20231221_9c6193a6-d824-1b27-e053-2995a90ab3cf.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 9 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medics Choice Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMK.C. Pharmaceuticals, Inc.9ddfc275-602f-413b-e053-2995a90a11cb2025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops Seasonal ReliefTETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEKC Pharmaceuticals, Inc.92bd8cb4-90ad-4a47-afa4-30d1fa658d622025-12-30WarningsExact identifier
application number: M018
DG Health Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLDolgencorp LLC9c62f8a3-7cf5-40f9-e053-2a95a90afd862025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops Original Redness RelieverTETRAHYDROZOLINE HYDROCHLORIDEKC Pharmaceuticals, Inc.e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be2025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEK.C. Pharmaceuticals, Inc.f7131707-47af-d70a-e053-6394a90a418f2025-12-30WarningsExact identifier
application number: M018
DG Original Eye DropsTETRAHYDROZOLINE HCLDolgencorp LLC9cb2123c-3ed4-ce8f-e053-2995a90a0ab82025-12-30WarningsExact identifier
application number: M018
Artificial TearsPOLYVINYL ALCOHOL, POVIDONEKC Pharmaceuticals, Inc.eb6eb6c4-1609-407b-84e4-c7509811f3c02025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops AdvancedTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONEKC Pharmaceuticals, Inc.ab906fd8-265c-4359-a920-d626366e245c2025-12-30WarningsExact identifier
application number: M018
Medics Choice Fresh and Soothe Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKC Pharmaceuticals, Inc.1f65b91a-4eac-65c2-e063-6394a90a02952025-12-30WarningsExact identifier
application number: M018
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
application number: M018
DG Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLDolgencorp LLC9cb27899-6c36-3c37-e053-2995a90a1d432025-12-30WarningsExact identifier
application number: M018
Publix Artificial Tears Eye DropsPOLYVINYL ALCOHOL, POVIDONEPublix Super Markets, Inc.f5d1394b-0fe8-c372-e053-2a95a90a1f782025-12-30WarningsExact identifier
application number: M018
Best Choice Artificial TearsPOLYVINYL ALCOHOL, POVIDONEBest Choicef5ba63f3-7966-81fe-e053-2995a90a342c2025-12-30WarningsExact identifier
application number: M018
DG Maximum Strength Redness ReliefGLYCERIN, NAPHAZOLINE HCLDolgencorp, Inc9cb261ed-b708-1189-e053-2a95a90a547d2025-12-30WarningsExact identifier
application number: M018
Publix Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEPublix Super Markets, Inc.f7b0c3d6-0324-46c3-e053-6394a90a82412025-12-30WarningsExact identifier
application number: M018
Publix Moisturizing Relief Eye DropsCARBOXYMETHYLCELLULOSE SODIUMPublix Super Markets, Inc.9b391400-c53b-7c7b-e053-2995a90a27312025-12-30WarningsExact identifier
application number: M018
Publix High Performance Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLPublix Super Markets, Inc.9b402aa8-87cb-3928-e053-2995a90afa3c2025-12-30WarningsExact identifier
application number: M018
Kroger Eye Drops Artificial TearsPOLYVINYL ALCOHOL, POVIDONEThe Kroger Companyf76f08c5-0111-8bc5-e053-6294a90a16ee2025-12-30WarningsExact identifier
application number: M018
Health Mart Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCc8be678f-2b4a-4d39-9cb4-910d36d721742025-12-30WarningsExact identifier
application number: M018
Winco Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLWinCo Foods, LLCff3651d4-42ce-4db1-a318-15f7592baf862025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235200glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSN9c6193a6-d824-1b27-e053-2995a90ab3cf3
1235200glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCD9c6193a6-d824-1b27-e053-2995a90ab3cf3
1235200glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSY9c6193a6-d824-1b27-e053-2995a90ab3cf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-975-01368000975011 BOTTLE, DROPPER in 1 CARTON (36800-975-01) / 15 mL in 1 BOTTLE, DROPPER2020-02-040000-00-00NoNoCurrent