FDA.reportPublic FDA data

NDC 50378-019 - Ovadine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50378-019
Package NDCs from labels
50378-019-54, 50378-019-50, 50378-019-51, 50378-019-55
Manufacturer
Western Chemical Inc. | BASF Corporation
Effective date
2020-07-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PVPI Solution - Western Chemical Inc. | BASF CorporationWestern Chemical Inc. | BASF Corporation2020-07-21OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50378-019-50Ovadine3.8 L in 1 BOTTLE, PLASTICSOLUTION3.81
50378-019-51Ovadine19 L in 1 PAILSOLUTION191
50378-019-54Ovadine208 L in 1 DRUMSOLUTION2081
50378-019-55Ovadine15.2 L in 1 CASESOLUTION15.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50378-019OVADINE (PVPI SOLUTION) SOLUTION [WESTERN CHEMICAL INC.]14 package rows20230728_2d167fa9-23b0-4353-8523-495b7d83439f.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 12 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
sterilePOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0658a0c8-f5ec-b380-e063-6394a90afff52025-01-08WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
unii: 85H0HZU99M
Aurodone Povidone Iodine 5 % Opthalmic SolutionPOVIDONE IODINE 5 % TOPICAL SOLUTIONAurolabf3444446-1dad-79ff-e053-2a95a90af4112025-01-06WarningsExact identifier
unii: 85H0HZU99M
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.41891599-420e-48d2-8e31-d28a2209e3832025-01-06WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.00002127-02bc-4c66-b0c3-ca29d8224afc2025-01-02WarningsExact identifier
unii: 85H0HZU99M
Povidone IodinePOVIDONE IODINE 10%Trifecta Pharmaceuticals USA LLCf80ccd8a-9b9b-bbf9-e053-6394a90ac8272024-12-20WarningsExact identifier
unii: 85H0HZU99M
Humco Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.1e078022-f32c-48bd-8add-f83aebcc58122024-12-18WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Foster and Thrive Povidone-IodinePOVIDONE IODINEStrategic Sourcing Services, LLC28621f29-ce45-c6dc-e063-6294a90aa5f72024-12-03WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
sterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdb1910bf8-9e96-4df1-8cca-6926102ad2352024-11-21WarningsExact identifier
unii: 85H0HZU99M
Amsino 10 Povidone-Iodine Solution 3 4 Fluid OuncePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd7ce1df35-479d-4ce5-b568-1ee72f7812bc2024-11-21WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Povidone-Iodine Solution SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd478e9d3c-42ff-4ccc-8dd8-6f690cd629d72024-11-21WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.