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 8 of 25 · 499 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medi-First Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Unifirst First Aid Corporation	a4e651cc-adf0-af9e-e053-2995a90ace5a	2025-12-30	Warnings	Exact identifier application number: M018
Green Guard Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	UniFirst First Aid Corporation	c3f04fdb-9fc1-797d-e053-2995a90afe80	2025-12-30	Warnings	Exact identifier application number: M018
EYE DROPS	CARBOXYMETHYLCELLULOSE SODIUM	Foshan Sugar Max Cosmetics CO.,Ltd	26dbf100-593e-3778-e063-6394a90adf26	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Original Formula	TETRAHYDROZOLINE HCL	Geiss, Destin & Dunn, Inc.	9b44de58-6362-3811-e053-2995a90a2f37	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Redness Relief Plus	GLLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Geiss, Destin & Dunn, Inc.	9b37250f-9bdf-574e-e053-2a95a90a013e	2025-12-30	Warnings	Exact identifier application number: M018
CVS Advanced Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	CVS Pharmacy, Inc.	f74a2fca-902c-f68a-e053-6394a90abb88	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Irritation Relief	TETRAHYDROZOLINE HCL, ZINC SULFATE	Geiss, Destin & Dunn, Inc.	9b24fbdd-780c-1ba2-e053-2a95a90ad60f	2025-12-30	Warnings	Exact identifier application number: M018
CVS Hydration Eye Drops	POLYETYLENE GLYCOL 400, PROPYLENE GLYCOL	CVS	ecab8fa3-6575-0dde-e053-2a95a90abd61	2025-12-30	Warnings	Exact identifier application number: M018
Good Sense Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Geiss, Destin & Dunn, Inc.	9b243301-2e4b-5706-e053-2995a90a9b90	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Geiss, Derstin & Dunn, Inc.	9b34de99-13df-201a-e053-2a95a90ae559	2025-12-30	Warnings	Exact identifier application number: M018
Good Sense Lubricating Plus Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	GoodSense	ffd6428e-3bf5-8742-e053-6394a90a4c8f	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Ultra Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Geiss, Destin & Dunn, Inc.	9b45ebb5-c43b-c9fb-e053-2a95a90a3411	2025-12-30	Warnings	Exact identifier application number: M018
CVS Maximum Redness Relief	GLYCERIN, NAPHAZOLINE HCI	CVS Pharmacy, Inc.	f70f9fc4-4022-336e-e053-6394a90a4d07	2025-12-30	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Discount Drug Mart, Inc.	f75c2f84-a28c-5807-e053-6294a90a2295	2025-12-30	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Discount Drug Mart	f7fd53be-e501-d97f-e053-6394a90ad409	2025-12-30	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	Discount Drug Mart	f5f1d3da-5300-8211-e053-2a95a90a323a	2025-12-30	Warnings	Exact identifier application number: M018
Exchange Select Eye Drops Advanced Relief Moisturizer	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Army and Air Force Exchange Service	9e475240-2df1-9bee-e053-2995a90a8d4b	2025-12-30	Warnings	Exact identifier application number: M018
Family Wellness Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Family Dollar Services, Inc.	facd53c4-9cfc-6589-e053-6394a90a180d	2025-12-30	Warnings	Exact identifier application number: M018
Exchange Select Artificial Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Army and Air Force Exchange Service	9e478343-8ae7-823e-e053-2995a90a84ed	2025-12-30	Warnings	Exact identifier application number: M018
Family Wellness Advanced Redness Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL	Family Dollar Services, Inc.	fabec215-a040-3f4e-e053-6394a90ad45f	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