Equaline Eye Drops A.C.

Product NDC: 41163-540
11-digit product format: 411630540
Labeler code: 41163
Product ID: 41163-540_0cfac3c3-6f4a-cc70-e063-6394a90a57b1
Type: HUMAN OTC DRUG
Nonproprietary name: tetrahydrozoline HCl, zinc sulfate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: United Natural Foods, Inc.
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-03-22
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: Equaline Eye Drops A.C.
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
f5f894f0-1ab0-4cad-e053-2995a90a7cba	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
41163-540-01	Equaline Eye Drops A.C.	1 in 1 CARTON	SOLUTION	1		2
41163-540-01	Equaline Eye Drops A.C.	15 mL in 1 BOTTLE, DROPPER	SOLUTION	15		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41163-540	EQUALINE EYE DROPS A.C. (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION [UNITED NATURAL FOODS, INC.]	2	Current NDC, 2 package rows	20231224_f5f894f0-1ab0-4cad-e053-2995a90a7cba.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 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 41163-540
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
GenTeal Tears Moderate Preservative Free	DEXTRAN 70, HYPROMELLOSE 2910	Alcon Laboratories, Inc.	37686e54-e64d-47c8-b082-b944a23cf6f1	2023-12-14	Warnings	Exact identifier application number: M018
Altachlore Sodium Chloride Hypertonicity	SODIUM CHLORIDE	Altaire Pharmaceuticals Inc.	dc0d94d8-4475-4956-8ded-bdb9496074e4	2023-12-09	Warnings	Exact identifier application number: M018
Altalube	MINERAL OIL AND PETROLATUM	Altaire Pharmaceuticals Inc.	eb65004c-c3a7-4079-bd75-f2857d30c68a	2023-12-09	Warnings	Exact identifier application number: M018
Good Neighbor Pharmacy Artifical Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Proficient Rx LP	73e12596-6dd5-4cd2-83ed-992e1211b4b8	2023-12-01	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	f5f894f0-1ab0-4cad-e053-2995a90a7cba	2
1043249	tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic Solution	SCD	f5f894f0-1ab0-4cad-e053-2995a90a7cba	2
1043249	tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic Solution	SY	f5f894f0-1ab0-4cad-e053-2995a90a7cba	2
1043249	Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic Solution	SY	f5f894f0-1ab0-4cad-e053-2995a90a7cba	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
41163-540-01	41163054001	1 BOTTLE, DROPPER in 1 CARTON (41163-540-01) / 15 mL in 1 BOTTLE, DROPPER	2023-03-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Equaline Eye Drops A.C.15 mL (PLD)	United Natural Foods, Inc. \| KC Pharmaceuticals, Inc. \| K.C. Pharmaceuticals, Inc.	2023-12-20	HUMAN OTC DRUG LABEL	2