FDA.reportPublic FDA data

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
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

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
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL
ZINC SULFATE.25 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0YZT43HS7D, 89DS0H96TB
Rxcui1043249

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-011-01CareOne Itchy Relief Eye Drops 15mL15 mL in 1 BOTTLE, DROPPERLIQUID153
72476-011-01CareOne Itchy Relief Eye Drops 15mL1 in 1 BOXLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-011CAREONE ITCHY RELIEF EYE DROPS 15ML (TETRAHYDROZOLINE HCI, ZINC SULFATE) LIQUID [RETAIL BUSINESS SERVICES, LLC.]2Current NDC, Legacy NDC, 2 package rows20250101_997f16ff-2632-2e9d-e053-2995a90a6f51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN997f16ff-2632-2e9d-e053-2995a90a6f513
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD997f16ff-2632-2e9d-e053-2995a90a6f513
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY997f16ff-2632-2e9d-e053-2995a90a6f513
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY997f16ff-2632-2e9d-e053-2995a90a6f513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72476-011-01724760011011 BOTTLE, DROPPER in 1 BOX (72476-011-01) / 15 mL in 1 BOTTLE, DROPPER2019-10-290000-00-00NoNoCurrent