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		2026-10-21
excluded package	package	72476-011	72476-011-01	D	Discontinued by firm		2026-10-21

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 16 of 25 · 486 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eyeleve MGD	MINERAL OIL	Bruder Healthcare	145b66e2-00e1-410e-8539-e12ffc4f6f82	2025-07-15	Warnings	Exact identifier application number: M018
Quality Choice Eye Drops Redness Relief	TETRAHYDROZOLINE HCL	Chain Drug Marketing Assoc., Inc.	38d2bc34-c6f0-a09c-e063-6394a90a69e1	2025-06-26	Warnings	Exact identifier application number: M018
Visine Red Eye Hydrating Comfort Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Morning Star OTC	dcd4164c-aa1e-4f07-ab2c-b439275629db	2025-06-16	Warnings	Exact identifier application number: M018
Code Red Eye Drops Micro	GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE	4 Trees LLC	2a15ea9a-ff67-446b-8b83-6517d25ff38a	2025-05-29	Warnings	Exact identifier application number: M018
Biotrue Hydration Boost	GLYCERIN	Bausch & Lomb Incorporated	e2621477-e6ee-4275-ba0a-939dca2550c4	2025-05-19	Warnings	Exact identifier application number: M018
Eyesaline Emergency Eyewash	STERILE EYESALINE EYEWASH	Honeywell Safety Products USA, Inc.	2d567518-4c54-7448-e063-6294a90a3e64	2025-05-14	Warnings	Exact identifier application number: M018
Splash Redness Reliever	HYPROMELLOSE, NAPHAZOLINE HYDROCHLORIDE	LABORATORIOS SOPHIA, S.A. DE C.V.	fa4140e6-dc80-da99-e053-6294a90a194f	2025-05-09	Warnings	Exact identifier application number: M018
Vista Gonio Eye Lubricant	HYPROMELLOSE OPHTHALMIC SOLUTION	Red Wedding LLC	00da365d-2988-9c9e-e063-6294a90a8931	2025-03-25	Warnings	Exact identifier application number: M018
Sodium Chloride	SODIUM CHLORIDE TABLET	Belleview Bioscience LLC	31195e8f-d4de-9e37-e063-6294a90a4156	2025-03-24	Warnings	Exact identifier application number: M018
Leader Nighttime Relief Lubricant Eye	LIGHT MINERAL OIL, WHITE PETROLATUM	LEADER/Cardinal Health 110, Inc.	308772fc-d6f6-da9f-e063-6394a90a41db	2025-03-12	Warnings	Exact identifier application number: M018
Clear Eyes Maximum Redness Relief	NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN	Prestige Brands Holdings, Inc.	c3b0e344-68dd-4c35-bf46-744e612a5b15	2025-02-28	Warnings	Exact identifier application number: M018
Blink Nourish Dry Eye	GLYCERIN	Bausch & Lomb Incorporated	cf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a4	2025-02-25	Warnings	Exact identifier application number: M018
Advanced Eye Relief Eye Wash	WATER SOLUTION	Bausch & Lomb Incorporated	9caccce1-4530-441d-bf76-244edeb9dedc	2025-02-17	Warnings	Exact identifier application number: M018
Hydropure Lubricating Eye Drops	GLYCERIN	OTE North America	17f5b6e5-dc14-45c7-e063-6294a90af43d	2025-02-14	Warnings	Exact identifier application number: M018
Walgreens Soothing Eye Relief Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Walgreens Co.	29b7387b-ad65-3a11-e063-6394a90a6a15	2025-02-14	Warnings	Exact identifier application number: M018
Eyesaline Eyewash Concentrate	PURIFIED WATER	Honeywell Safety Products, Inc.	2d90c8e8-f479-3535-e063-6394a90af122	2025-02-07	Warnings	Exact identifier application number: M018
Code Red Eye Drops Redness Relief	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL	4 Trees, LLC	0aa08018-cc2d-d947-e063-6394a90a914a	2025-02-07	Warnings	Exact identifier application number: M018
Tyson 2.0 Mike Red Eye Drops For Dry High Eyes	GLYCERIN, NAPHAZOLINE HCL	Jbrands Pharma L.L.C.	288e9c85-0562-89bf-e063-6394a90a110d	2025-02-07	Warnings	Exact identifier application number: M018
Sodium Chloride Normal Salt	SODIUM CHLORIDE	Citragen Pharmaceuticals Inc	aae783b2-18fe-69ca-e053-2a95a90a0800	2025-01-30	Warnings	Exact identifier application number: M018
Sodium Chloride Normal Salt	SODIUM CHLORIDE	Citragen Pharmaceuticals Inc	82c29f1d-a018-7483-e053-2a91aa0a8f7e	2025-01-30	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