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

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 Identifiers#

Field, Values table
FieldValues
Unii532B59J990, FZ989GH94E
Rxcui359969

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

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