FDA.reportPublic FDA data

REFRESH Classic

Product NDC
0023-0506
11-digit product format
000230506
Labeler code
0023
Product ID
0023-0506_58d49977-1915-4473-801d-a28b87b9a328
Type
HUMAN OTC DRUG
Nonproprietary name
Polyvinyl Alcohol, Povidone
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1985-09-12
Substance
POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE
Active strength
14; 6 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
REFRESH Classic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYVINYL ALCOHOL, UNSPECIFIED14 mg/mL
POVIDONE6 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-0506-01REFRESH Classic0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.411
0023-0506-01REFRESH Classic30 in 1 CARTONSOLUTION/ DROPS3011
0023-0506-50REFRESH Classic50 in 1 CARTONSOLUTION/ DROPS5011
0023-0506-50REFRESH Classic0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-0506-01EA - Each0023-05066f103f52-b51b-4112-8b6f-0dbff9ac462a12012-07-24
0023-0506-50EA - Each0023-0506d349c8e5-b120-43bc-a75d-eb0c165a554e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Polyvinyl AlcoholACTIVE INGREDIENT532B59J990REFRESH CLASSIC (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [ALLERGAN, INC.]4
PovidoneACTIVE INGREDIENTFZ989GH94EREFRESH CLASSIC (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [ALLERGAN, INC.]4
Polyvinyl AlcoholACTIVE MOIETY532B59J990REFRESH CLASSIC (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [ALLERGAN, INC.]4
PovidoneACTIVE MOIETYFZ989GH94EREFRESH CLASSIC (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [ALLERGAN, INC.]4
hydrochloric acidINACTIVE INGREDIENTQTT17582CBREFRESH CLASSIC (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [ALLERGAN, INC.]4
sodium chlorideINACTIVE INGREDIENT451W47IQ8XREFRESH CLASSIC (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [ALLERGAN, INC.]4
sodium hydroxideINACTIVE INGREDIENT55X04QC32IREFRESH CLASSIC (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [ALLERGAN, INC.]4
waterINACTIVE INGREDIENT059QF0KO0RREFRESH CLASSIC (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [ALLERGAN, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-0506REFRESH CLASSIC (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [ALLERGAN, INC.]10Current NDC, Legacy NDC, 4 package rows20240214_31bf1d6c-9719-4060-b6a3-409a2fe7b560.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 5 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRedicare LLC4d1e5089-22b0-7b3f-e063-6294a90a346a2026-03-16WarningsExact identifier
application number: M018
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
application number: M018
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
application number: M018
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
application number: M018
Focus PIHYPROMELLOSE EYE DROPS 0.7%COVALENT MEDICALe9b2afdd-049a-3987-e053-2a95a90a6cbb2026-03-09WarningsExact identifier
application number: M018
Rain Renewal Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRain Eye Drops, LLCbb451b22-c4f6-291d-e053-2a95a90a78012026-03-06WarningsExact identifier
application number: M018
Complete Eye Relief Sterile Lubricant Eye DropsHYDROXYETHYL CELLULOSESimilasan Corporation4c49493a-70f9-0fde-e063-6394a90aea202026-03-05WarningsExact identifier
application number: M018
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
application number: M018
Irritated Eye Relief Sterile Lubricant Eye DropsHYDROXYETHYL CELLULOSESimilasan Corporation4c4ddcdf-3037-c9cd-e063-6294a90a16d52026-03-05WarningsExact identifier
application number: M018
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
application number: M018
Discount Drug Mart Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMDiscount Drug Mart4ba1b369-54e2-5224-e063-6394a90a47692026-02-25WarningsExact identifier
application number: M018
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4bafa882-50b7-e3e2-e063-6294a90a76e32026-02-25WarningsExact identifier
application number: M018
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
application number: M018
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
application number: M018
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
application number: M018
OptaseWHITE PETROLATUM, LANOLINScope Health Incc1991caa-51b9-13d1-e053-2995a90a12932026-01-31WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359969polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic SolutionPSN3bf6193c-56db-45ad-844c-58eb8c33cba918
359969polyvinyl alcohol 0.014 ML/ML / povidone 6 MG/ML Ophthalmic SolutionSCD3bf6193c-56db-45ad-844c-58eb8c33cba918
359969polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic SolutionSY3bf6193c-56db-45ad-844c-58eb8c33cba918
359969polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic SolutionPSN31bf1d6c-9719-4060-b6a3-409a2fe7b56011
359969polyvinyl alcohol 0.014 ML/ML / povidone 6 MG/ML Ophthalmic SolutionSCD31bf1d6c-9719-4060-b6a3-409a2fe7b56011
359969polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic SolutionSY31bf1d6c-9719-4060-b6a3-409a2fe7b56011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-0506-010002305060130 VIAL, SINGLE-USE in 1 CARTON (0023-0506-01) / .4 mL in 1 VIAL, SINGLE-USE1985-09-120000-00-00NoNoCurrent
0023-0506-500002305065050 VIAL, SINGLE-USE in 1 CARTON (0023-0506-50) / .4 mL in 1 VIAL, SINGLE-USE1985-09-120000-00-00NoNoCurrent