FDA.reportPublic FDA data

Polyvinyl Alcohol

Product NDC
50090-7119
11-digit product format
500907119
Labeler code
50090
Product ID
50090-7119_f9bfe960-da7e-40f4-9242-3d9008311473
Type
HUMAN OTC DRUG
Nonproprietary name
Polyvinyl Alcohol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-05
Substance
POLYVINYL ALCOHOL
Active strength
14 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
Polyvinyl Alcohol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYVINYL ALCOHOL14 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
142004Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c77589fd-f68d-48b7-bd12-51f6b4cc9402Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7119-0Polyvinyl Alcohol15 mL in 1 BOTTLESOLUTION/ DROPS151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7119-0ML - Milliliter50090-711988db554a-f3fa-4cb2-9eca-b02d065f624412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7119POLYVINYL ALCOHOL SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20240322_c77589fd-f68d-48b7-bd12-51f6b4cc9402.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
142004polyvinyl alcohol 1.4 % Ophthalmic SolutionPSNc77589fd-f68d-48b7-bd12-51f6b4cc94021
142004polyvinyl alcohol 0.014 ML/ML Ophthalmic SolutionSCDc77589fd-f68d-48b7-bd12-51f6b4cc94021
142004polyvinyl alcohol 1.4 % Ophthalmic SolutionSYc77589fd-f68d-48b7-bd12-51f6b4cc94021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7119-05009071190015 mL in 1 BOTTLE (50090-7119-0) 15 ml2024-03-19NoNoCurrent