Topcare Health Ultra Itch Relief Astringent Eye Drops

Product NDC: 36800-855
11-digit product format: 368000855
Labeler code: 36800
Product ID: 36800-855_0cfa87ca-f1d4-c578-e063-6394a90a7626
Type: HUMAN OTC DRUG
Nonproprietary name: tetrahydrozoline HCl, zinc sulfate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Topco Associates LLC
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-02-01
Substance: TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Active strength: .05; .25 g/100mL; g/100mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Ultra Itch Relief Astringent Eye Drops
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TETRAHYDROZOLINE HYDROCHLORIDE	.05 g/100mL
ZINC SULFATE	.25 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0YZT43HS7D	Internal UNII lookup
89DS0H96TB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043249	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
9c617e34-fc64-1a5b-e053-2995a90ace2c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
27945931-b6e2-158e-d615-4ef21e2af974	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-855-01	Topcare Health Ultra Itch Relief Astringent Eye Drops	1 in 1 CARTON	SOLUTION	1		3
36800-855-01	Topcare Health Ultra Itch Relief Astringent Eye Drops	15 mL in 1 BOTTLE, DROPPER	SOLUTION	15		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-855	TOPCARE HEALTH ULTRA ITCH RELIEF ASTRINGENT EYE DROPS (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION [TOPCO ASSOCIATES LLC]	3	Current NDC, Legacy NDC, 2 package rows	20231221_9c617e34-fc64-1a5b-e053-2995a90ace2c.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Winco Original Formula Eye Drops	TETRAHYDROZOLINE HCL	WinCo Foods, LLC	44266952-4054-4c12-b3fc-d0543fe54fe2	2025-12-30	Warnings	Exact identifier application number: M018
Winco Irritation Relief Eye	TETRAHYDROZOLINE HCL, ZINC SULFATE	WinCo Foods, LLC	60565184-5745-43a5-92b2-ab45b27e8bc6	2025-12-30	Warnings	Exact identifier application number: M018
Core Values Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Liberty Procurement Co. Inc.	f8285f68-c40c-19a8-e053-6394a90aacad	2025-12-30	Warnings	Exact identifier application number: M018
Core Values Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Liberty Procurement Co., Inc.	f76dfeca-4e86-0b5d-e053-6294a90a29b9	2025-12-30	Warnings	Exact identifier application number: M018
Best Choice Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	Best Choice (Valu Merchandisers Company)	f5e665e4-ebd7-8c35-e053-2995a90a8811	2025-12-30	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Artificial Tears	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Harris Teeter, LLC.	f82957d9-c4ad-a914-e053-6294a90aac50	2025-12-30	Warnings	Exact identifier application number: M018
Best Choice Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Valu Merchandisers, Co.	f7491a17-8035-5a3c-e053-6294a90a615c	2025-12-30	Warnings	Exact identifier application number: M018
Winco Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	WinCo Foods, LLC	f10778c8-14fe-4852-8b73-42db502fd2bc	2025-12-30	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Maximum Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Harris Teeter, LLC	f710d107-0403-21c5-e053-6394a90a0372	2025-12-30	Warnings	Exact identifier application number: M018
CVS Astringent Eye	TETRAHYDROZOLINE HCL, ZINC SULFATE	CVS Pharmacy, Inc.	07e1a56b-fdad-408d-bf5a-7a0144ece131	2025-12-30	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Harris Teeter, LLC	f76e2831-5c6c-7a62-e053-6294a90a937b	2025-12-30	Warnings	Exact identifier application number: M018
CVS Gentle Tears	DEXTRAN 70, HYPROMELLOSE	CVS Pharmacy, Inc.	9b1ea0eb-c34f-6603-e053-2995a90a6a95	2025-12-30	Warnings	Exact identifier application number: M018
CVS Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	CVS Pharmacy, Inc.	8eef499d-c60e-9468-e053-2995a90a8714	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Lubricating Tears Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	0042337b-c22a-157a-e063-6394a90a202e	2025-12-30	Warnings	Exact identifier application number: M018
CVS Lubricant Eye Drops Original	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CVS	bb1ad35a-79ea-639f-e053-2995a90a96f3	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Advanced Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL	Strategic Sourcing Services LLC	0019cd99-b245-2ffc-e063-6294a90a9f27	2025-12-30	Warnings	Exact identifier application number: M018
CVS Multi-Symptom Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	CVS Pharmacy, Inc.	be3d7855-cc66-ace8-e053-2a95a90ab8f4	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Dry Eye Relief	POLYETHYLENE GLYCOL 400	Strategic Sourcing Services LLC	0018ade9-5856-db6c-e063-6394a90a2ccf	2025-12-30	Warnings	Exact identifier application number: M018
CareOne Itchy Relief Eye Drops 15mL	TETRAHYDROZOLINE HCI, ZINC SULFATE	Retail Business Services, LLC.	997f16ff-2632-2e9d-e053-2995a90a6f51	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Strategic Sourcing Services LLC	0042e9a0-9693-d7e0-e063-6294a90ae6c6	2025-12-30	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0YZT43HS7D	TETRAHYDROZOLINE HYDROCHLORIDE	522-48-5	TETRAHYDROZOLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043249	tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic Solution	PSN	9c617e34-fc64-1a5b-e053-2995a90ace2c	3
1043249	tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic Solution	SCD	9c617e34-fc64-1a5b-e053-2995a90ace2c	3
1043249	tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic Solution	SY	9c617e34-fc64-1a5b-e053-2995a90ace2c	3
1043249	Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic Solution	SY	9c617e34-fc64-1a5b-e053-2995a90ace2c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-855-01	36800085501	1 BOTTLE, DROPPER in 1 CARTON (36800-855-01) / 15 mL in 1 BOTTLE, DROPPER	2020-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topcare Ultra Itch Relief Astringent (PLD)	Topco Associates LLC \| K.C. Pharmaceuticals, Inc.	2023-12-20	HUMAN OTC DRUG LABEL	3