FDA.reportPublic FDA data

Kroger Eye Drops Artificial Tears

Product NDC
59450-814
11-digit product format
594500814
Labeler code
59450
Product ID
59450-814_4748f329-7732-16b1-e063-6394a90a7579
Type
HUMAN OTC DRUG
Nonproprietary name
Polyvinyl alcohol, Povidone
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
The Kroger Company
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-20
Substance
POVIDONE; POLYVINYL ALCOHOL, UNSPECIFIED
Active strength
.6; .5 g/100mL; g/100mL
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
Kroger Eye Drops Artificial Tears
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE.6 g/100mL
POLYVINYL ALCOHOL, UNSPECIFIED.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FZ989GH94EInternal UNII lookup
532B59J990Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
598050Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f76f08c5-0111-8bc5-e053-6294a90a16eeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59450-814-01Kroger Eye Drops Artificial Tears1 in 1 CARTONSOLUTION/ DROPS13
59450-814-01Kroger Eye Drops Artificial Tears15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-814KROGER EYE DROPS ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [THE KROGER COMPANY]2Current NDC, 2 package rows20231224_f76f08c5-0111-8bc5-e053-6294a90a16ee.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyeleve MGDMINERAL OILBruder Healthcare145b66e2-00e1-410e-8539-e12ffc4f6f822025-07-15WarningsExact identifier
application number: M018
Quality Choice Eye Drops Redness ReliefTETRAHYDROZOLINE HCLChain Drug Marketing Assoc., Inc.38d2bc34-c6f0-a09c-e063-6394a90a69e12025-06-26WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Morning Star OTCdcd4164c-aa1e-4f07-ab2c-b439275629db2025-06-16WarningsExact identifier
application number: M018
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
application number: M018
Biotrue Hydration BoostGLYCERINBausch & Lomb Incorporatede2621477-e6ee-4275-ba0a-939dca2550c42025-05-19WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
application number: M018
Splash Redness RelieverHYPROMELLOSE, NAPHAZOLINE HYDROCHLORIDELABORATORIOS SOPHIA, S.A. DE C.V.fa4140e6-dc80-da99-e053-6294a90a194f2025-05-09WarningsExact identifier
application number: M018
Vista Gonio Eye LubricantHYPROMELLOSE OPHTHALMIC SOLUTIONRed Wedding LLC00da365d-2988-9c9e-e063-6294a90a89312025-03-25WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
application number: M018
Leader Nighttime Relief Lubricant EyeLIGHT MINERAL OIL, WHITE PETROLATUMLEADER/Cardinal Health 110, Inc.308772fc-d6f6-da9f-e063-6394a90a41db2025-03-12WarningsExact identifier
application number: M018
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
application number: M018
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
application number: M018
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
application number: M018
Hydropure Lubricating Eye DropsGLYCERINOTE North America17f5b6e5-dc14-45c7-e063-6294a90af43d2025-02-14WarningsExact identifier
application number: M018
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
application number: M018
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
application number: M018
Code Red Eye Drops Redness ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL4 Trees, LLC0aa08018-cc2d-d947-e063-6394a90a914a2025-02-07WarningsExact identifier
application number: M018
Tyson 2.0 Mike Red Eye Drops For Dry High EyesGLYCERIN, NAPHAZOLINE HCLJbrands Pharma L.L.C.288e9c85-0562-89bf-e063-6394a90a110d2025-02-07WarningsExact identifier
application number: M018
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Incaae783b2-18fe-69ca-e053-2a95a90a08002025-01-30WarningsExact identifier
application number: M018
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Inc82c29f1d-a018-7483-e053-2a91aa0a8f7e2025-01-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionPSNf76f08c5-0111-8bc5-e053-6294a90a16ee3
598050polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML Ophthalmic SolutionSCDf76f08c5-0111-8bc5-e053-6294a90a16ee3
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionSYf76f08c5-0111-8bc5-e053-6294a90a16ee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59450-814-01594500814011 BOTTLE, DROPPER in 1 CARTON (59450-814-01) / 15 mL in 1 BOTTLE, DROPPER2023-03-20NoNoCurrent