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 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
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