Visine A.C. Itchy Eye Relief

Product NDC: 69968-0366
11-digit product format: 699680366
Labeler code: 69968
Product ID: 69968-0366_21d8bf17-920a-739e-e063-6294a90a2882
Type: HUMAN OTC DRUG
Nonproprietary name: Tetrahydrozoline Hydrochloride and Zinc Sulfate, Unspecified Form
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Kenvue Brands LLC
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-05-06
Substance: TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE, UNSPECIFIED FORM
Active strength: .5; 2.5 mg/mL; mg/mL
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: Visine A.C. Itchy Eye Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TETRAHYDROZOLINE HYDROCHLORIDE	.5 mg/mL
ZINC SULFATE, UNSPECIFIED FORM	2.5 mg/mL

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
257b9666-0163-499b-9673-bf6f4d6899b1	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
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
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
69968-0366-1	Visine A.C. Itchy Eye Relief	1 in 1 CARTON	SOLUTION/ DROPS	1		3
69968-0366-1	Visine A.C. Itchy Eye Relief	15 mL in 1 BOTTLE	SOLUTION/ DROPS	15		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69968-0366	VISINE A.C. ITCHY EYE RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORM) SOLUTION/ DROPS [KENVUE BRANDS LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241115_257b9666-0163-499b-9673-bf6f4d6899b1.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 24 of 25 · 499 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Health Advanced Moisturizing Plus Redness Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Topco Associates LLC	9c6193a6-d822-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Topco Assoc LLC	9c6193a6-d824-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier application number: M018
HEB Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	HEB	5d522e4d-d647-486f-a947-25c14b1417fa	2023-12-20	Warnings	Exact identifier application number: M018
HEB A.C. Eye Drops	TETRAHYDROZOLINE HCL, ZINC SULFATE	HEB Grocery Company., LP	f680a8c1-dc91-7a52-e053-2a95a90a571e	2023-12-20	Warnings	Exact identifier application number: M018
HEB Advanced Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	HEB Grocery Company, LP	f76281d6-3aea-349b-e053-6394a90afca2	2023-12-20	Warnings	Exact identifier application number: M018
Equaline Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	United Natural Foods, Inc.	f5f894f0-1ab0-4cad-e053-2995a90a7cba	2023-12-20	Warnings	Exact identifier application number: M018
Cleareyes Redness Relief	NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN	Lil' Drug Store Products, Inc.	39e4ab2b-ae12-4339-b219-109cf0f7f06a	2023-12-15	Warnings	Exact identifier application number: M018
GenTeal Tears (Moderate)	DEXTRAN 70, GLYCERIN, HYPROMELLOSE	Alcon Laboratories, Inc.	a2992597-3490-6a5c-be45-2b6fa15e1547	2023-12-15	Warnings	Exact identifier application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREE	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	db3a6c68-320b-46b0-83fa-6c29297a84a6	2023-12-15	Warnings	Exact identifier application number: M018
Systane	POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL	Alcon Research Ltd	14916d2c-a63d-491e-bd91-a61f300af38a	2023-12-15	Warnings	Exact identifier application number: M018
Systane	HYPROMELLOSE	Alcon Laboratories, Inc.	5f74b161-ae41-d0e2-6ed9-8deca55d2c0f	2023-12-15	Warnings	Exact identifier application number: M018
Systane Day and Night Value Pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%	Alcon Laboratories, Inc.	df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07	2023-12-15	Warnings	Exact identifier application number: M018
Systane Lubricant	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	15bc06ec-f3dc-3180-ca1a-106769a770ea	2023-12-15	Warnings	Exact identifier application number: M018
Systane ULTRA	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	a5c1c194-3db5-4f18-9cd1-97f7f84c3cff	2023-12-15	Warnings	Exact identifier application number: M018
Systane COMPLETE PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	7eaa93ca-c843-4c89-921b-c76659410dce	2023-12-14	Warnings	Exact identifier application number: M018
BION TEARS	DEXTRAN, HYPROMELLOSE	Alcon Laboratories, Inc.	e48d82f0-2f18-e514-4caa-e397d6713b99	2023-12-14	Warnings	Exact identifier application number: M018
GenTeal Tears Severe	HYPROMELLOSE	Alcon Laboratories, Inc.	a57854fc-f3a2-4fbb-b718-cd06f87a721e	2023-12-14	Warnings	Exact identifier application number: M018
BION TEARS	DEXTRAN, HYPROMELLOSE	Alcon Laboratories, Inc.	538c2a89-efb5-4132-b678-5a78f23cb713	2023-12-14	Warnings	Exact identifier application number: M018
GenTeal Tears Gel Drops	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	84388a75-9d11-48ce-bf5a-88f0580d2d03	2023-12-14	Warnings	Exact identifier application number: M018
Alcon Tears Lubricant Eye Drops	HYPROMELLOSE 2910	Alcon Laboratories, Inc.	89302e2b-882b-48d5-8df7-be37859b48ba	2023-12-14	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
89DS0H96TB	ZINC SULFATE, UNSPECIFIED FORM		ZINC SULFATE, UNSPECIFIED FORM

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	257b9666-0163-499b-9673-bf6f4d6899b1	3
1043249	tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic Solution	SCD	257b9666-0163-499b-9673-bf6f4d6899b1	3
1043249	tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic Solution	SY	257b9666-0163-499b-9673-bf6f4d6899b1	3
1043249	Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic Solution	SY	257b9666-0163-499b-9673-bf6f4d6899b1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69968-0366-1	69968036601	1 BOTTLE in 1 CARTON (69968-0366-1) / 15 mL in 1 BOTTLE	1 bottle	2019-05-06	0000-00-00	No	No	Current