FDA.reportPublic FDA data

REFRESH CLASSIC

Product NDC
50090-2358
11-digit product format
500902358
Labeler code
50090
Product ID
50090-2358_2a6ae637-2f65-4a5f-99d3-e3560f67b8f0
Type
HUMAN OTC DRUG
Nonproprietary name
Polyvinyl Alcohol, Povidone
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1985-09-12
Substance
POLYVINYL ALCOHOL; POVIDONE
Active strength
14; 6 mg/mL; mg/mL
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
REFRESH CLASSIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYVINYL ALCOHOL14 mg/mL
POVIDONE6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359969Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3bf6193c-56db-45ad-844c-58eb8c33cba9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2358-12023-02-07C16284748780-1f386c64a-03fc-0266-e053-dadaa90a7c1aREFRESH CLASSIC
50090-2358-12023-01-30C16284748780-1f386c64a-03fc-0266-e053-dadaa90a7c1aREFRESH CLASSIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2358-1REFRESH CLASSIC30 in 1 CARTONSOLUTION/ DROPS3018
50090-2358-1REFRESH CLASSIC.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS.418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2358-1EA - Each50090-2358d52774bd-6c4e-4090-870a-10d4222167c412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2358REFRESH CLASSIC (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 2 package rows20240316_3bf6193c-56db-45ad-844c-58eb8c33cba9.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 3 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
application number: M018
Nano Eye Drop SerumWATER. SORBITOL.1.2-HEXANEDIOL GLYCERIN HYALURONATESODIUM.Shenzhen Yiyang Zhiting Technology Co., Ltd539567d6-488a-9b01-e063-6394a90abece2026-06-06WarningsExact identifier
application number: M018
REFRESH CELLUVISCCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.b32ed9e8-d091-4f16-b416-5a62cdfee49a2026-06-05WarningsExact identifier
application number: M018
VitaPhyte Redness Reliever Lubricant Eye DropsREDNESS RELIEVER LUBRICANT EYE DROPSGuangzhou Liyan Cosmetics Technology Co., Ltd.53d4e9b0-c9a0-797a-e063-6294a90ad0cf2026-06-04WarningsExact identifier
application number: M018
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
application number: M018
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
application number: M018
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
application number: M018
Blink Triple Care Preservative FreePOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated65e67990-78b7-4ce9-963b-6bed3a6bed072026-05-27WarningsExact identifier
application number: M018
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
application number: M018
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
application number: M018
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporatedf1d07347-086f-43b2-aa5f-910764fc666e2026-05-13WarningsExact identifier
application number: M018
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
application number: M018
Sodium Hyaluronate Eye DropsSODIUM HYALURONATEGuangzhou Hechuang Commercial Service Co.,Ltd.5187d136-15c6-517b-e063-6294a90a811d2026-05-11WarningsExact identifier
application number: M018
Splash TearsHYPROMELLOSELABORATORIOS SOPHIA, S.A. DE C.V.a58a8478-9cc5-aa39-e053-2995a90a347d2026-05-08WarningsExact identifier
application number: M018
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
application number: M018
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
application number: M018
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2358-15009023580130 VIAL, SINGLE-USE in 1 CARTON (50090-2358-1) / .4 mL in 1 VIAL, SINGLE-USE2016-04-210000-00-00NoNoCurrent