FDA.reportPublic FDA data

TopCare Health Advanced Moisturizing Plus Redness Relief

Product NDC
36800-856
11-digit product format
368000856
Labeler code
36800
Product ID
36800-856_0cfa88e0-a3dd-180c-e063-6294a90ae2ac
Type
HUMAN OTC DRUG
Nonproprietary name
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Topco Associates LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-04
Substance
POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 400; DEXTRAN 70
Active strength
1; .05; 1; .1 g/100mL; g/100mL; g/100mL; g/100mL
Pharmacologic classes
Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [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 Health Advanced Moisturizing Plus Redness Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE1 g/100mL
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL
POLYETHYLENE GLYCOL 4001 g/100mL
DEXTRAN 70.1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FZ989GH94EInternal UNII lookup
0YZT43HS7DInternal UNII lookup
B697894SGQInternal UNII lookup
7SA290YK68Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996202Internal 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-d822-1b27-e053-2995a90ab3cfAvailable 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
36800-856-01TopCare Health Advanced Moisturizing Plus Redness Relief15 mL in 1 BOTTLE, DROPPERSOLUTION153
36800-856-01TopCare Health Advanced Moisturizing Plus Redness Relief1 in 1 CARTONSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-856TOPCARE HEALTH ADVANCED MOISTURIZING PLUS REDNESS RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20231221_9c6193a6-d822-1b27-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 10 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Winco Original Formula Eye DropsTETRAHYDROZOLINE HCLWinCo Foods, LLC44266952-4054-4c12-b3fc-d0543fe54fe22025-12-30WarningsExact identifier
application number: M018
Winco Irritation Relief EyeTETRAHYDROZOLINE HCL, ZINC SULFATEWinCo Foods, LLC60565184-5745-43a5-92b2-ab45b27e8bc62025-12-30WarningsExact identifier
application number: M018
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
application number: M018
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
application number: M018
Best Choice Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEBest Choice (Valu Merchandisers Company)f5e665e4-ebd7-8c35-e053-2995a90a88112025-12-30WarningsExact identifier
application number: M018
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
application number: M018
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
application number: M018
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
application number: M018
Harris Teeter Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLCf710d107-0403-21c5-e053-6394a90a03722025-12-30WarningsExact identifier
application number: M018
CVS Astringent EyeTETRAHYDROZOLINE HCL, ZINC SULFATECVS Pharmacy, Inc.07e1a56b-fdad-408d-bf5a-7a0144ece1312025-12-30WarningsExact identifier
application number: M018
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
application number: M018
CVS Gentle TearsDEXTRAN 70, HYPROMELLOSECVS Pharmacy, Inc.9b1ea0eb-c34f-6603-e053-2995a90a6a952025-12-30WarningsExact identifier
application number: M018
CVS Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMCVS Pharmacy, Inc.8eef499d-c60e-9468-e053-2995a90a87142025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Lubricating Tears Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC0042337b-c22a-157a-e063-6394a90a202e2025-12-30WarningsExact identifier
application number: M018
CVS Lubricant Eye Drops OriginalPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVSbb1ad35a-79ea-639f-e053-2995a90a96f32025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLStrategic Sourcing Services LLC0019cd99-b245-2ffc-e063-6294a90a9f272025-12-30WarningsExact identifier
application number: M018
CVS Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATECVS Pharmacy, Inc.be3d7855-cc66-ace8-e053-2a95a90ab8f42025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Dry Eye ReliefPOLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC0018ade9-5856-db6c-e063-6394a90a2ccf2025-12-30WarningsExact identifier
application number: M018
CareOne Itchy Relief Eye Drops 15mLTETRAHYDROZOLINE HCI, ZINC SULFATERetail Business Services, LLC.997f16ff-2632-2e9d-e053-2995a90a6f512025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLStrategic Sourcing Services LLC0042e9a0-9693-d7e0-e063-6294a90ae6c62025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN9c6193a6-d822-1b27-e053-2995a90ab3cf3
996202dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD9c6193a6-d822-1b27-e053-2995a90ab3cf3
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionSY9c6193a6-d822-1b27-e053-2995a90ab3cf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-856-01368000856011 BOTTLE, DROPPER in 1 CARTON (36800-856-01) / 15 mL in 1 BOTTLE, DROPPER2020-02-040000-00-00NoNoCurrent