TopCare Health Original Eye Drops

Product NDC: 36800-858
11-digit product format: 368000858
Labeler code: 36800
Product ID: 36800-858_0cfa5c76-fce8-9f22-e063-6394a90ade89
Type: HUMAN OTC DRUG
Nonproprietary name: tetrahydrozoline HCl
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Topco Associates LLC
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-02-06
Substance: TETRAHYDROZOLINE HYDROCHLORIDE
Active strength: .05 g/100mL
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 Original Eye Drops
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1052943	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
9c61a56a-c1a9-2846-e053-2995a90a755b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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
36800-858-01	TopCare Health Original Eye Drops	1 in 1 CARTON	SOLUTION	1		3
36800-858-01	TopCare Health Original 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
36800-858	TOPCARE HEALTH ORIGINAL EYE DROPS (TETRAHYDROZOLINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	3	Current NDC, Legacy NDC, 2 package rows	20231221_9c61a56a-c1a9-2846-e053-2995a90a755b.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 22 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meijer Maximum Redness Relief and Lubricant	GLYCERIN, NAPHAZOLINE HCI	Meijer Distribution, Inc.	9feb1818-c79b-23bf-e053-2995a90a1084	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Redness Relief	TETRAHYDROZOLINE HCI	Meijer Distribution, Inc.	9fea27a5-b81b-1598-e053-2995a90a6b62	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Seasonal Itching and Redness Relief	TETRAHYDROZOLINE HCI, ZINC SULFATE	Meijer Distribution, Inc.	9fead2de-2fe6-4dab-e053-2995a90a2742	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Meijer Distribution, Inc.	9feb3eec-a36f-8fc7-e053-2a95a90adcd3	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Redness Relief	GLYCERIN, NAPHAZOLINE HCI	Meijer Distribution, Inc.	9fea4e43-7525-bb66-e053-2a95a90acee9	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Ultra Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Meijer Distribution, Inc.	a0846e3e-687c-fd55-e053-2995a90a673e	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Advanced Redness and Irritation Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI	Meijer Distribution, Inc.	9fea6d7a-a2cd-d26e-e053-2995a90a15f8	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Meijer Distribution, Inc.	9feaa5e2-6aca-96e8-e053-2a95a90a54bd	2023-12-22	Warnings	Exact identifier application number: M018
Walgreens Multi-Symptom Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Walgreen Co.	a03789ce-66bd-7b12-e053-2995a90af85a	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Lubricant Eye Drops Preservative Free	DEXTRAN 70, HYPROMELLOSE	Walgreen Company	9b383e41-e116-1c12-e053-2a95a90ab25f	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Eye Drops Maximum Redness Relief 15mL	GLYCERIN, NAPHAZOLINE HCI	Walgreen Company	949d4a4d-b0f8-81f8-e053-2995a90a818d	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Eye Drops Seasonal Relief 15mL	TETRAHYDROZOLINE HCI, ZINC SULFATE	Walgreen Co.	947f3706-ef5e-2c53-e053-2a95a90a82bd	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Eye Drops Advanced Relief 15mL	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI	Walgreen Company	949f5560-fba7-2da8-e053-2995a90a23c2	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Lubricant Eye Drops Preservative Free	CARBOXYMETHYLCELLULOSE SODIUM	Walgreen Company	9912b773-e7a5-3a82-e053-2995a90a5b2c	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Lubricant Eye Drops High Performance 15mL and twin pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walgreen Company	94ee8310-1c19-dfd4-e053-2a95a90a8356	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Redness Relief Eye Drops 15mL	GLYCERIN, NAPHAZOLINE HCI	Walgreen Company	94a0d08a-a6db-1088-e053-2995a90ab4fd	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Eye Drops Original 15mL and twin pack	TETRAHYDROZOLINE HCI	Walgreens Company	94e391f7-db4b-47d2-e053-2a95a90a1b11	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walgreen Company	94f6e1cd-073c-61ca-e053-2a95a90ae725	2023-12-20	Warnings	Exact identifier application number: M018
Lubricant Eye Drops Preservative Free	CARBOXYMETHYLCELLULOSE SODIUM	Target Corporation	454ce049-49e5-48b1-8499-048e5e7d72d3	2023-12-20	Warnings	Exact identifier application number: M018
Rugby Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Rugby Laboratories	f9292d5d-e0a3-9287-e053-6294a90a43e9	2023-12-20	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
1052943	tetrahydrozoline HCl 0.05 % Ophthalmic Solution	PSN	9c61a56a-c1a9-2846-e053-2995a90a755b	3
1052943	tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution	SCD	9c61a56a-c1a9-2846-e053-2995a90a755b	3
1052943	tetrahydrozoline hydrochloride 0.05 % Eye Drops	SY	9c61a56a-c1a9-2846-e053-2995a90a755b	3
1052943	tetrahydrozoline hydrochloride 0.05 % Ophthalmic Solution	SY	9c61a56a-c1a9-2846-e053-2995a90a755b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-858-01	36800085801	1 BOTTLE, DROPPER in 1 CARTON (36800-858-01) / 15 mL in 1 BOTTLE, DROPPER	2020-02-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TopCare Health Original Eye Drops (PLD)	Topco Associates LLC \| K.C. Pharmaceuticals, Inc \| K.C. Pharmaceuticals, Inc.	2023-12-20	HUMAN OTC DRUG LABEL	3