FDA.reportPublic FDA data

FLORIL TEARS

Product NDC
16995-002
11-digit product format
169950002
Labeler code
16995
Product ID
16995-002_6becdef5-06d3-4a24-b46b-c8bb682a1339
Type
HUMAN OTC DRUG
Nonproprietary name
POLYVINYL ALCOHOL
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
VITALINE S.A.C.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-11-10
Marketing end
0000-00-00
Substance
POLYVINYL ALCOHOL; POLYETHYLENE GLYCOL 400
Active strength
14 mL/mL; mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16995-002-012019-10-21C16284748780-1956f9ecf-dbde-621f-e053-dbdaa90a74ad22125054-98e6-47de-a56f-91ca54c318c4
16995-002-022019-10-21C16284748780-1956f9ecf-dbde-621f-e053-dbdaa90a74ad22125054-98e6-47de-a56f-91ca54c318c4
16995-002-032019-10-21C16284748780-1956f9ecf-dbde-621f-e053-dbdaa90a74ad22125054-98e6-47de-a56f-91ca54c318c4
16995-002-042019-10-21C16284748780-1956f9ecf-dbde-621f-e053-dbdaa90a74ad22125054-98e6-47de-a56f-91ca54c318c4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16995-002-01FLORIL TEARS3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS32
16995-002-02FLORIL TEARS10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS102
16995-002-03FLORIL TEARS15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
16995-002-04FLORIL TEARS30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQFLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]2
POLYVINYL ALCOHOLACTIVE INGREDIENT532B59J990FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]2
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQFLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]2
POLYVINYL ALCOHOLACTIVE MOIETY532B59J990FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]2
WATERINACTIVE INGREDIENT059QF0KO0RFLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16995-002FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]2Legacy NDC, 4 package rows20100108_22125054-98e6-47de-a56f-91ca54c318c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039907Floril TEARS 0.2 % / 1.4 % Ophthalmic SolutionPSN22125054-98e6-47de-a56f-91ca54c318c42
1039905polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % Ophthalmic SolutionPSN22125054-98e6-47de-a56f-91ca54c318c42
1039907polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution [Floril Tears]SBD22125054-98e6-47de-a56f-91ca54c318c42
1039905polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML Ophthalmic SolutionSCD22125054-98e6-47de-a56f-91ca54c318c42
1039907Floril Tears (polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % ) Ophthalmic SolutionSY22125054-98e6-47de-a56f-91ca54c318c42
1039907Floril Tears (polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML) Ophthalmic SolutionSY22125054-98e6-47de-a56f-91ca54c318c42
1039905polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % Ophthalmic SolutionSY22125054-98e6-47de-a56f-91ca54c318c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
16995-002-01169950002013 mL in 1 BOTTLE, DROPPER3 mlHistorical
16995-002-021699500020210 mL in 1 BOTTLE, DROPPER10 mlHistorical
16995-002-031699500020315 mL in 1 BOTTLE, DROPPER15 mlHistorical
16995-002-041699500020430 mL in 1 BOTTLE, DROPPER30 mlHistorical