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 11 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CareOne Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCI	Retail Business Services, LLC	9ab96aed-21d3-11b6-e053-2995a90a7225	2025-12-30	Warnings	Exact identifier application number: M018
CVS Lubricant Eye Drops 30 ct	CARBOXYMETHYLCELLULOSE SODUIM	CVS Pharmacy, Inc.	8dbca077-c989-767a-e053-2995a90a7cf5	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Original Formula Eye Drops	TETRAHYDROZOLINE HCL	Strategic Sourcing Services LLC	002da62b-aec6-8e2a-e063-6294a90a5efc	2025-12-30	Warnings	Exact identifier application number: M018
CareOne Artificial Tears Eye Drops 15mL	POLYVINYL ALCOHOL, POVIDONE	Retail Business Services, LLC	92fded6b-91fd-d82e-e053-2a95a90ab523	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Long Lasting Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	00546df0-17d8-0e3c-e063-6294a90ae7b2	2025-12-30	Warnings	Exact identifier application number: M018
Meijer Multi-Symptom Relief	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Meijer, Inc.	e7a5677a-ff33-c039-e053-2a95a90ae6c7	2025-12-30	Warnings	Exact identifier application number: M018
TopCare Health Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Topcare Associates LLC	e8e9dfe5-3540-a4df-e053-2a95a90aaf98	2025-12-30	Warnings	Exact identifier application number: M018
Meijer Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Meijer Distribution, Inc.	b245f99f-785a-efdc-e053-2995a90a4911	2025-12-30	Warnings	Exact identifier application number: M018
Equate Original Eye Drops	TETRAHYDROZOLINE HCL	Walmart, Inc.	eb8e5beb-4454-58c2-e053-2a95a90a66e0	2025-12-30	Warnings	Exact identifier application number: M018
Avenova Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	NovaBay Pharmaceuticals, Inc.	cd17f037-5aa5-0ef8-e053-2a95a90a39cb	2025-12-30	Warnings	Exact identifier application number: M018
Equate Redness and Dry Eye Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Wal-Mart Stores, Inc.	ae228018-9238-2cbd-e053-2995a90a8d99	2025-12-30	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walmart, Inc.	deebaf7f-f20d-4d7f-e053-2a95a90a4b4f	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Artificial Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Chain Drug Marketing Association, Inc.	1f669655-4bc7-0175-e063-6294a90a305a	2025-12-30	Warnings	Exact identifier application number: M018
Equate Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Walmart, Inc.	ead9f271-0f15-1fff-e053-2a95a90a93ac	2025-12-30	Warnings	Exact identifier application number: M018
Equate Multi-Symptom Relief Eye Drops	POLYETHYLENE GLYCOL 400,TETRAHYDROZOLINE HCL, ZINC SULFATE	Walmart, Inc.	eb8ed76b-9cd7-3636-e053-2a95a90a9583	2025-12-30	Warnings	Exact identifier application number: M018
CorneaCare Recover Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CorneaCare Inc.	1fd3a5ed-8963-5c8e-e063-6394a90a6527	2025-12-30	Warnings	Exact identifier application number: M018
Eye Love Heyedrate Long Lasting Hydration	GLYCERIN, POVIDONE	Physician Recommended Neutraceuticals, L.P.	f321dea1-3251-eaa8-e053-2995a90aaf95	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Chain Drug Marketing Assoc., Inc.	0cd1b36a-a07a-a1db-e063-6294a90a5994	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Eye Drops Irritation Relief	TETRAHYDROZOLINE HCL, ZINC SULFATE	Quality Choice	1f682079-6e91-e14b-e063-6394a90a3f12	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Moisturizing Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Chain Drug Marketing Association, Inc.	1fb81759-5931-59c8-e063-6294a90a2277	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