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 21 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Discount Drug Mart Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Discount Drug Mart, Inc.	31a98e6c-42df-6b56-e063-6294a90a3564	2024-01-01	Warnings	Exact identifier application number: M018
Harris Teeter Ultra Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Harris Teeter, LLC.	31ac6883-ffc6-39de-e063-6294a90a52dd	2024-01-01	Warnings	Exact identifier application number: M018
Exchange Select High Performance Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Army and Air Force Exchange Service	31ac8bd2-c2e9-6f2c-e063-6394a90adc72	2024-01-01	Warnings	Exact identifier application number: M018
CVS Health Fast Acting Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CVS Pharmacy, Inc.	31addfd2-52f2-05b3-e063-6294a90a337f	2024-01-01	Warnings	Exact identifier application number: M018
Equate Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Wal-Mart Stores, Inc.	91fb8fb5-b871-4535-e053-2995a90a9b16	2023-12-23	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops Preservative-Free	CARBOXYMETHYLCELLULOSE SODIUM	Wal-Mart Stores, Inc.	9228a39b-38d2-1dfc-e053-2a95a90a3c90	2023-12-23	Warnings	Exact identifier application number: M018
Equate Restore Plus Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Walmart, Inc.	9e665ca2-4fa6-fdb4-e053-2a95a90abcca	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Eye Drops Advanced Moisturizer/Lubricant	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE	Strategic Sourcing Services LLC	0daa4e39-0447-44b6-a7d7-370b12bf9451	2023-12-23	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Wal-Mart Stores, Inc.	91f85a72-5270-e4db-e053-2995a90aeb21	2023-12-23	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Wal-Mart Stores, Inc.	e32233ef-ea15-45b8-8e83-b658cf4c56a0	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Eye Drops Original Formula	TETRAHYDROZOLINE HCL	Strategic Sourcing Services LLC	33efa7e9-4c3a-4d72-af31-c5e35095c2ff	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Lubricant Eye Drops	POLYPROPYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	b117ff0a-1a48-4022-96e6-52bc45f056fc	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Strategic Sourcing Services LLC	043ccc34-44ee-416a-88bc-f247774e9075	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Lubricating Tears	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	58f0b6d7-6072-40fd-ba72-b3ed68834791	2023-12-23	Warnings	Exact identifier application number: M018
Leader Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Cardinal Health	8d9a4eec-bf0e-6c3b-e053-2995a90ae9aa	2023-12-23	Warnings	Exact identifier application number: M018
Leader Eye Wash	PURIFIED WATER	Cardinal Health	8d3ad11f-1945-f838-e053-2995a90a7aa5	2023-12-23	Warnings	Exact identifier application number: M018
Good Neighbor Pharmacy Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Amerisource Bergen Drug Corp.	fd2dc23f-6ccc-2644-e053-6294a90a889e	2023-12-23	Warnings	Exact identifier application number: M018
Rite Aid Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Rite Aid Corporation	fa1b5b66-9643-e9a7-e053-6394a90ae3cf	2023-12-23	Warnings	Exact identifier application number: M018
Signature Care Lubricant Eye Drops Long Lasting	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Better Living Brands, LLC	05a63929-fccd-2936-e063-6294a90aeac5	2023-12-23	Warnings	Exact identifier application number: M018
Meijer Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Meijer Distribution, Inc.	9feadde4-fbe5-0c9e-e053-2995a90a9b30	2023-12-22	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