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 25 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Lubricating DropsPOLYVINYL ALCOHOLA-S Medication Solutionsf2e26f85-4081-425b-9c81-ac2a079a57432023-11-10WarningsExact identifier
application number: M018
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
application number: M018
Eyeganics Organic TearsGLYCERINEyeganics LLC42470af7-a3ae-4e14-88e0-04cd92db4b372023-10-13WarningsExact identifier
application number: M018
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
application number: M018
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
application number: M018
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
application number: M018
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
application number: M018
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
application number: M018
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
application number: M018
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
application number: M018
REFRESH P.M.MINERAL OIL, PETROLATUMAllergan, Inc.24365d64-cd94-41cc-a7e1-033102d981142022-06-30WarningsExact identifier
application number: M018
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
application number: M018
CIRCLE K sterile eye dropsTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0e106c-16f6-ff4e-e063-6294a90a7dbb2018-07-30WarningsExact identifier
application number: M018
Lil Drug Store Sterile Eye Drops Redness RelieverTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0ea35c-ac52-1043-e063-6394a90a061c2018-04-30WarningsExact 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