FDA.reportPublic FDA data

CareOne Maximum Redness Relief Eye Drops

Product NDC
72476-012
11-digit product format
724760012
Labeler code
72476
Product ID
72476-012_47492a43-35f5-5c2c-e063-6394a90a5b7f
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin, Naphazoline HCI
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Retail Business Services, LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-12
Substance
GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Active strength
.5; .03 g/100mL; g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 Maximum Redness Relief Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN.5 g/100mL
NAPHAZOLINE HYDROCHLORIDE.03 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
MZ1131787DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1235200Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9ab96aed-21d3-11b6-e053-2995a90a7225Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-012-01CareOne Maximum Redness Relief Eye Drops1 in 1 BOXSOLUTION/ DROPS14
72476-012-01CareOne Maximum Redness Relief Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-012CAREONE MAXIMUM REDNESS RELIEF EYE DROPS (GLYCERIN, NAPHAZOLINE HCI) SOLUTION/ DROPS [RETAIL BUSINESS SERVICES, LLC]3Current NDC, Legacy NDC, 2 package rows20240104_9ab96aed-21d3-11b6-e053-2995a90a7225.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 24 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
application number: M018
Equaline Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEUnited Natural Foods, Inc.f5f894f0-1ab0-4cad-e053-2995a90a7cba2023-12-20WarningsExact identifier
application number: M018
Cleareyes Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINLil' Drug Store Products, Inc.39e4ab2b-ae12-4339-b219-109cf0f7f06a2023-12-15WarningsExact identifier
application number: M018
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.db3a6c68-320b-46b0-83fa-6c29297a84a62023-12-15WarningsExact identifier
application number: M018
SystanePOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLAlcon Research Ltd14916d2c-a63d-491e-bd91-a61f300af38a2023-12-15WarningsExact identifier
application number: M018
SystaneHYPROMELLOSEAlcon Laboratories, Inc.5f74b161-ae41-d0e2-6ed9-8deca55d2c0f2023-12-15WarningsExact identifier
application number: M018
Systane Day and Night Value PackPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%Alcon Laboratories, Inc.df13ca6f-7ce1-455a-ae13-9bbc5e9d2e072023-12-15WarningsExact identifier
application number: M018
Systane LubricantPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.15bc06ec-f3dc-3180-ca1a-106769a770ea2023-12-15WarningsExact identifier
application number: M018
Systane ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
application number: M018
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.7eaa93ca-c843-4c89-921b-c76659410dce2023-12-14WarningsExact identifier
application number: M018
BION TEARSDEXTRAN, HYPROMELLOSEAlcon Laboratories, Inc.e48d82f0-2f18-e514-4caa-e397d6713b992023-12-14WarningsExact identifier
application number: M018
GenTeal Tears SevereHYPROMELLOSEAlcon Laboratories, Inc.a57854fc-f3a2-4fbb-b718-cd06f87a721e2023-12-14WarningsExact identifier
application number: M018
BION TEARSDEXTRAN, HYPROMELLOSEAlcon Laboratories, Inc.538c2a89-efb5-4132-b678-5a78f23cb7132023-12-14WarningsExact identifier
application number: M018
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
application number: M018
Alcon Tears Lubricant Eye DropsHYPROMELLOSE 2910Alcon Laboratories, Inc.89302e2b-882b-48d5-8df7-be37859b48ba2023-12-14WarningsExact identifier
application number: M018
GenTeal Tears Moderate Preservative FreeDEXTRAN 70, HYPROMELLOSE 2910Alcon Laboratories, Inc.37686e54-e64d-47c8-b082-b944a23cf6f12023-12-14WarningsExact identifier
application number: M018
Altachlore Sodium Chloride HypertonicitySODIUM CHLORIDEAltaire Pharmaceuticals Inc.dc0d94d8-4475-4956-8ded-bdb9496074e42023-12-09WarningsExact identifier
application number: M018
AltalubeMINERAL OIL AND PETROLATUMAltaire Pharmaceuticals Inc.eb65004c-c3a7-4079-bd75-f2857d30c68a2023-12-09WarningsExact identifier
application number: M018
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235200glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSN9ab96aed-21d3-11b6-e053-2995a90a72254
1235200glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCD9ab96aed-21d3-11b6-e053-2995a90a72254
1235200glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSY9ab96aed-21d3-11b6-e053-2995a90a72254

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72476-012-01724760012011 BOTTLE, DROPPER in 1 BOX (72476-012-01) / 15 mL in 1 BOTTLE, DROPPER2020-01-120000-00-00NoNoCurrent