CareOne Itchy Relief Eye Drops 15mL

Product NDC: 72476-011
11-digit product format: 724760011
Labeler code: 72476
Product ID: 72476-011_4749275b-6984-4eaf-e063-6394a90aaee9
Type: HUMAN OTC DRUG
Nonproprietary name: Tetrahydrozoline HCI, Zinc sulfate
Dosage form: LIQUID
Route: OPHTHALMIC
Labeler: Retail Business Services, LLC.
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-10-29
Substance: ZINC SULFATE; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength: .25; .05 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72476-011		D	Discontinued by firm		2026-10-15
excluded package	package	72476-011	72476-011-01	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72476-011-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72476-011-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72476-011-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72476-011-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72476-011-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72476-011-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72476-011-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72476-011-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72476-011-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72476-011-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72476-011-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72476-011-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: CareOne Itchy Relief Eye Drops 15mL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC SULFATE	.25 g/100mL
TETRAHYDROZOLINE HYDROCHLORIDE	.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89DS0H96TB	Internal UNII lookup
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
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
997f16ff-2632-2e9d-e053-2995a90a6f51	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
72476-011-01	CareOne Itchy Relief Eye Drops 15mL	15 mL in 1 BOTTLE, DROPPER	LIQUID	15		3
72476-011-01	CareOne Itchy Relief Eye Drops 15mL	1 in 1 BOX	LIQUID	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72476-011	CAREONE ITCHY RELIEF EYE DROPS 15ML (TETRAHYDROZOLINE HCI, ZINC SULFATE) LIQUID [RETAIL BUSINESS SERVICES, LLC.]	2	Current NDC, Legacy NDC, 2 package rows	20250101_997f16ff-2632-2e9d-e053-2995a90a6f51.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 5 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Redicare LLC	4d1e5089-22b0-7b3f-e063-6294a90a346a	2026-03-16	Warnings	Exact identifier application number: M018
Leader Ultra Lubricating Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Cardinal Health	d7f011a2-05ba-47c3-9519-d31602e105c7	2026-03-12	Warnings	Exact identifier application number: M018
Leader Restorative Formula Lubricant Eye Drops	PROPYLENE GLYCOL	Cardinal Health	87fef7e4-e5a8-4aad-94d2-f80f34826d97	2026-03-12	Warnings	Exact identifier application number: M018
Leader Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Cardinal Health	5c5d6c13-9b51-48f0-8627-b60b0f707fd3	2026-03-12	Warnings	Exact identifier application number: M018
Focus PI	HYPROMELLOSE EYE DROPS 0.7%	COVALENT MEDICAL	e9b2afdd-049a-3987-e053-2a95a90a6cbb	2026-03-09	Warnings	Exact identifier application number: M018
Rain Renewal Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Rain Eye Drops, LLC	bb451b22-c4f6-291d-e053-2a95a90a7801	2026-03-06	Warnings	Exact identifier application number: M018
Complete Eye Relief Sterile Lubricant Eye Drops	HYDROXYETHYL CELLULOSE	Similasan Corporation	4c49493a-70f9-0fde-e063-6394a90aea20	2026-03-05	Warnings	Exact identifier application number: M018
Dry Eye Relief Sterile Lubricant Eye Drops	GLYCERIN	Similasan Corporation	4c4cce1c-392e-354d-e063-6294a90a0ca3	2026-03-05	Warnings	Exact identifier application number: M018
Irritated Eye Relief Sterile Lubricant Eye Drops	HYDROXYETHYL CELLULOSE	Similasan Corporation	4c4ddcdf-3037-c9cd-e063-6294a90a16d5	2026-03-05	Warnings	Exact identifier application number: M018
Refresh Optive Mega-3 PF	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	326cb5d6-c784-404f-9a13-6d69262dda6e	2026-03-01	Warnings	Exact identifier application number: M018
Discount Drug Mart Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Discount Drug Mart	4ba1b369-54e2-5224-e063-6394a90a4769	2026-02-25	Warnings	Exact identifier application number: M018
Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	KC Pharmaceuticals, Inc.	4bafa882-50b7-e3e2-e063-6294a90a76e3	2026-02-25	Warnings	Exact identifier application number: M018
Viva Hydration Boost	GLYCERIN	Nomax Inc	174193b2-65eb-b5fd-e063-6394a90a9cd0	2026-02-10	Warnings	Exact identifier application number: M018
Droptics Performance Eye Drops	NAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOL	Droptics LLC	20fd6822-a7fd-4593-92bb-0a07260893e2	2026-02-09	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Sportpharm LLC	8d58dcbb-72a0-41f0-9eeb-613072a6d7ae	2026-02-06	Warnings	Exact identifier application number: M018
MINIDROPS	LUBRICANT EYE DROPS	Optics Laboratory, Inc	c13c5f91-50df-471c-a7c9-1747a2ac1250	2026-02-03	Warnings	Exact identifier application number: M018
Optase	WHITE PETROLATUM, LANOLIN	Scope Health Inc	c1991caa-51b9-13d1-e053-2995a90a1293	2026-01-31	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	376e0289-28e9-e87f-e063-6294a90a3b04	2026-01-30	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	10c3e31d-779d-8ff6-e063-6294a90acd39	2026-01-30	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	9e96976b-2990-79e0-e053-2995a90a0f29	2026-01-30	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	997f16ff-2632-2e9d-e053-2995a90a6f51	3
1043249	tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic Solution	SCD	997f16ff-2632-2e9d-e053-2995a90a6f51	3
1043249	tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic Solution	SY	997f16ff-2632-2e9d-e053-2995a90a6f51	3
1043249	Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic Solution	SY	997f16ff-2632-2e9d-e053-2995a90a6f51	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72476-011-01	72476001101	1 BOTTLE, DROPPER in 1 BOX (72476-011-01) / 15 mL in 1 BOTTLE, DROPPER	2019-10-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CareOne Itchy Relief Eye Drops 15mL (PLD)	Retail Business Services, LLC. \| KC Pharmaceuticals, Inc.	2025-12-30	HUMAN OTC DRUG LABEL	3