Artificial Tears

Product NDC
13985-601
11-digit product format
139850601
Labeler code
13985
Product ID
13985-601_3f0ac098-2e15-4967-a9c6-e061e4388755
Type
HUMAN OTC DRUG
Nonproprietary name
Polyvinyl Alcohol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
MWI
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-03-23
Marketing end
0000-00-00
Substance
POLYVINYL ALCOHOL, UNSPECIFIED
Active strength
14 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13985-601-152024-01-30C16284748780-11030e365-6556-111a-e063-dadaa90a10e2b6bf402a-fe57-4998-b85e-a262c25e745a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-601-15Artificial Tears15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155
13985-601-15Artificial Tears1 in 1 CARTONSOLUTION/ DROPS15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Polyvinyl AlcoholACTIVE INGREDIENT532B59J990ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]1
Polyvinyl AlcoholACTIVE MOIETY532B59J990ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]1
Sodium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENT22ADO53M6FARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]1
Sodium Phosphate, Monobasic, AnhydrousINACTIVE INGREDIENTKH7I04HPUUARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]1
WaterINACTIVE INGREDIENT059QF0KO0RARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-601ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]5Legacy NDC, 2 package rows20220209_b6bf402a-fe57-4998-b85e-a262c25e745a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142004polyvinyl alcohol 1.4 % Ophthalmic SolutionPSNb6bf402a-fe57-4998-b85e-a262c25e745a5
142004polyvinyl alcohol 0.014 ML/ML Ophthalmic SolutionSCDb6bf402a-fe57-4998-b85e-a262c25e745a5
142004polyvinyl alcohol 1.4 % Ophthalmic SolutionSYb6bf402a-fe57-4998-b85e-a262c25e745a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13985-601-15139850601151 BOTTLE, DROPPER in 1 CARTON (13985-601-15) > 15 mL in 1 BOTTLE, DROPPER2015-03-230000-00-00NoNoCurrent