FDA.reportPublic FDA data

Viva

Product NDC
54891-001
11-digit product format
548910001
Labeler code
54891
Product ID
54891-001_349765d3-ac03-48f9-ab37-5b92676b902f
Type
HUMAN OTC DRUG
Nonproprietary name
Polysorbate 80
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Dakota Laboratories, LLC
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1987-02-19
Marketing end
0000-00-00
Substance
POLYSORBATE 80
Active strength
100 mg/10mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54891-001-022019-11-13C16284748780-197449f38-b7a1-f6ea-e053-dbdaa90aa703Drug Facts
54891-001-032019-11-13C16284748780-197449f38-b7a1-f6ea-e053-dbdaa90aa703Drug Facts
54891-001-042019-11-13C16284748780-197449f38-b7a1-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54891-001-02Viva10 mL in 1 BOTTLESOLUTION/ DROPS1017
54891-001-03Viva.5 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS.517
54891-001-04Viva.5 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS.517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54891-001-02ML - Milliliter54891-0010d38d99e-aae5-42a1-805c-05654efc55ca12012-07-24
54891-001-04EA - Each54891-00197988c6d-72bc-48d5-9c7a-a61304aa339412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Polysorbate 80ACTIVE INGREDIENT6OZP39ZG8HVIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]17
SorbitanACTIVE MOIETY6O92ICV9RUVIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]17
Citric AcidINACTIVE INGREDIENT2968PHW8QPVIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]17
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KVIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]17
MannitolINACTIVE INGREDIENT3OWL53L36AVIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]17
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XVIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]17
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRVIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]17
Sodium PyruvateINACTIVE INGREDIENTPOD38AIF08VIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]17
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCVIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]17
WATERINACTIVE INGREDIENT059QF0KO0RVIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54891-001VIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]17Legacy NDC, 3 package rows20120203_45ac4335-3ecd-4a03-865e-82dd9cd3c715.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998224polysorbate 80 1 % Ophthalmic SolutionPSN45ac4335-3ecd-4a03-865e-82dd9cd3c71517
1090072VIVA Drops 1 % Ophthalmic SolutionPSN45ac4335-3ecd-4a03-865e-82dd9cd3c71517
1090072polysorbate 80 10 MG/ML Ophthalmic Solution [Viva-Drops Lubricating Eye Drops]SBD45ac4335-3ecd-4a03-865e-82dd9cd3c71517
998224polysorbate 80 10 MG/ML Ophthalmic SolutionSCD45ac4335-3ecd-4a03-865e-82dd9cd3c71517
998224polysorbate 80 1 % Ophthalmic SolutionSY45ac4335-3ecd-4a03-865e-82dd9cd3c71517
1090072Viva-Drops 1 % Lubricating Eye DropsSY45ac4335-3ecd-4a03-865e-82dd9cd3c71517
1090072Viva-Drops Lubricating Eye Drops 10 MG/ML Ophthalmic SolutionSY45ac4335-3ecd-4a03-865e-82dd9cd3c71517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54891-001-025489100010210 mL in 1 BOTTLE10 mlHistorical
54891-001-0354891000103.5 mL in 1 VIAL, SINGLE-USEHistorical
54891-001-0454891000104.5 mL in 1 VIAL, SINGLE-USEHistorical