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 15 of 25 · 486 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dry Eye Relief	CARBOXYMETHYLCELLULOSE SODIUM	CARDINAL HEALTH 110, LLC. DBA LEADER	bd262028-32e9-052d-e053-2a95a90a5303	2025-09-12	Warnings	Exact identifier application number: M018
Oasis TEARS PF PLUS Preservative-Free Lubricant Eye	GLYCERIN	OASIS Medical, Inc.	5d080191-423d-4c0a-b5ae-2ccf5c4a67cb	2025-09-08	Warnings	Exact identifier application number: M018
Physicians Care Eyewash	EYEWASH	Acme United Corporation	3e239b12-9a75-339d-e063-6294a90a72ae	2025-09-06	Warnings	Exact identifier application number: M018
Splash Refresh	HYPROMELLOSE	LABORATORIOS SOPHIA, S.A. DE C.V.	3c1c453e-2644-622a-e063-6394a90a8a94	2025-09-02	Warnings	Exact identifier application number: M018
Refresh RELIEVA PF	CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN	Allergan, Inc.	d5d3df4a-a311-4f2d-9a24-edfec1a6c9f9	2025-08-22	Warnings	Exact identifier application number: M018
Refresh Optive	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	Allergan, Inc.	37e99aa8-02d6-4efb-a862-90bc7fcd5ca5	2025-08-22	Warnings	Exact identifier application number: M018
Stye	MINERAL OIL AND PETROLATUM	Insight Pharmaceuticals LLC	f7eb8466-d8ea-4833-9bed-244ead38a3bf	2025-08-11	Warnings	Exact identifier application number: M018
Systane COMPLETE	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	2df0de02-a3e2-471a-9e10-040c3fba75fe	2025-08-08	Warnings	Exact identifier application number: M018
Medics Choice Fresh and Soothe	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	Unimed	3bcd8394-f486-d306-e063-6294a90a4e9a	2025-08-07	Warnings	Exact identifier application number: M018
Systane Balance	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	c7b1a03a-a5f2-409e-a34a-d6f166671de5	2025-08-07	Warnings	Exact identifier application number: M018
Medics Choice Fresh and Soothe	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	KC Pharmaceuticals, Inc.	3bc03d54-6b31-5921-e063-6294a90af599	2025-08-01	Warnings	Exact identifier application number: M018
LubriFresh PM	LIGHT MINERAL OIL, WHITE PETROLATUM	Hanlim Pharm Co. , LTD	3b329232-a562-6893-e063-6394a90aa41f	2025-07-31	Warnings	Exact identifier application number: M018
Systane Ultra	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	0537c23a-15f7-be64-1231-a6c93468e9a8	2025-07-30	Warnings	Exact identifier application number: M018
Systane	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	1d679d0f-cec2-a644-79cd-079607254bb9	2025-07-30	Warnings	Exact identifier application number: M018
Systane Ultra Preservative Free	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	751fb85f-6683-4b0a-a650-324d4a74c5de	2025-07-30	Warnings	Exact identifier application number: M018
Systane COMPLETE PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	99b63d62-1cf0-4f28-8760-773917c2538a	2025-07-29	Warnings	Exact identifier application number: M018
LubriFresh PM	LIGHT MINERAL OIL, WHITE PETROLATUM	Major Pharmaceuticals	3ab32e69-b8da-f187-e063-6294a90afa9a	2025-07-24	Warnings	Exact identifier application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops	POLYVINYL ALCOHOL	A-S Medication Solutions	2653e4fc-4f08-426d-a0a4-31d647c1de56	2025-07-18	Warnings	Exact identifier application number: M018
Focus Tears PF	CARBOXYMETHYLCELLULOSE SODIUM	Covalent Medical	772c7070-82ff-4371-b071-940ff91372c6	2025-07-17	Warnings	Exact identifier application number: M018
SilkTears	GLYCERIN OPHTHALMIC SOLUTION	SilkTears	3866e2c1-051b-0b01-e063-6394a90af5cf	2025-07-16	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