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 7 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vis Guard Lubricant Eye Drops	POLYVINYL ALCOHOL 1.4%	Ulai Health LLC	e9b0ed39-60c8-1093-e053-2a95a90a705b	2026-01-13	Warnings	Exact identifier application number: M018
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	AvPAK	b4697319-438e-2ec8-e053-2a95a90abb56	2026-01-08	Warnings	Exact identifier application number: M018
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	AvPAK	b478a695-ded0-2e5f-e053-2995a90ac45e	2026-01-08	Warnings	Exact identifier application number: M018
Lubricant Eye Drops Solution	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	AvPAK	f5743b38-e3d2-a065-e053-2995a90a4b9a	2026-01-08	Warnings	Exact identifier application number: M018
Plus Rinse Emergency Eyewash	PURIFIED WATER	INNOVATIVE SAFETY SUPPLY INC.	b3f47d26-39e4-4aea-bb92-358def52b652	2026-01-08	Warnings	Exact identifier application number: M018
pH Neutral Emergency Eyewash	WATER	INNOVATIVE SAFETY SUPPLY INC.	29a1bd1e-d0dd-478f-e063-6394a90ab0aa	2026-01-08	Warnings	Exact identifier application number: M018
Polyvinyl Alcohol Eye Drops 1,4 % w/v	POLYVINYL ALCOHOL EYE DROPS 1,4 % W/V	Aurolab	e8e09719-6e06-612b-e053-2995a90a79fc	2026-01-08	Warnings	Exact identifier application number: M018
Aurovisc	HYPROMELLOSE OPHTHALMIC SOLUTION 2% W/V	Aurolab	e9100312-b105-50a6-e053-2a95a90ac31f	2026-01-08	Warnings	Exact identifier application number: M018
TheraTears Dry and Tired	CARBOXYMETHYLCELLULOSE SODIUM	MEDTECH PRODUCTS INC	02b70e2d-8159-4637-a282-9eac1468e786	2026-01-07	Warnings	Exact identifier application number: M018
VISTA Hypromellose Dry Eye Relief	HYPROMELLOSE	Red Wedding LLC	b2c4954c-ed53-778a-e053-2a95a90ae0d0	2026-01-01	Warnings	Exact identifier application number: M018
Colirio Ojo De Aguila Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Grandall Distributing Co., Inc.	31aa07e9-0cc9-2a77-e063-6394a90a4b9d	2025-12-31	Warnings	Exact identifier application number: M018
Value Health by Prodose Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Prodose, Inc.	3fafa362-a8a6-3f91-e063-6394a90a98b3	2025-12-31	Warnings	Exact identifier application number: M018
Signature Care Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Better Living Brands LLC	6f1f4f58-3208-4b06-9afb-c4beeed09314	2025-12-30	Warnings	Exact identifier application number: M018
Target Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Target Corporation	6c449374-8847-4c4a-9073-1951ff31d404	2025-12-30	Warnings	Exact identifier application number: M018
Target Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Target Corporation	ddc15dac-fbd8-42fa-80db-79f49fc6b9eb	2025-12-30	Warnings	Exact identifier application number: M018
Nighttime Relief Lubricant	LIGHT MINERAL OIL, WHITE PETROLATUM	Amerisource Bergen Drug Corp.	fd6b2be8-7e00-3765-e053-6294a90a4061	2025-12-30	Warnings	Exact identifier application number: M018
Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Rugby Laboratories	fb84fc0b-9a62-812a-e053-6394a90aba0a	2025-12-30	Warnings	Exact identifier application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops	POLYVINYL ALCOHOL	Rugby Laboratories	081673b2-5c74-1200-e063-6394a90ae363	2025-12-30	Warnings	Exact identifier application number: M018
Medi-First Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Unifirst First Aid Corporation	a4e651cc-adf0-af9e-e053-2995a90ace5a	2025-12-30	Warnings	Exact identifier application number: M018
Green Guard Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	UniFirst First Aid Corporation	c3f04fdb-9fc1-797d-e053-2995a90afe80	2025-12-30	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