FDA.reportPublic FDA data

NDC 65734-511-00 - Isodine Copitos

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
65734-511
Requested NDC
65734-511-00
Package NDCs from labels
65734-511-00, 65734-511-72
Manufacturer
Swabplus Inc.
Effective date
2015-02-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isodine CopitosSwabplus Inc.2015-02-16HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65734-511-722020-01-31C16284748780-19d75b9cf-d73c-f424-e053-dadaa90a57ceIsodine Copitos

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65734-511-00Isodine Copitos0.15 mL in 1 APPLICATORSOLUTION0.152
65734-511-72Isodine Copitos72 in 1 PACKAGESOLUTION722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65734-511ISODINE COPITOS (POVIDONE-IODINE ) SOLUTION [SWABPLUS INC.]2Legacy NDC, 2 package rows20150224_8629d5dd-2a59-4184-89e5-d63b77e66226.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Povidone-IodineACTIVE INGREDIENT85H0HZU99MISODINE COPITOS (POVIDONE-IODINE ) SOLUTION [SWABPLUS INC.]2
IodineACTIVE MOIETY9679TC07X4ISODINE COPITOS (POVIDONE-IODINE ) SOLUTION [SWABPLUS INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXISODINE COPITOS (POVIDONE-IODINE ) SOLUTION [SWABPLUS INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IISODINE COPITOS (POVIDONE-IODINE ) SOLUTION [SWABPLUS INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RISODINE COPITOS (POVIDONE-IODINE ) SOLUTION [SWABPLUS INC.]2

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 8 of 37 · 728 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
Marlido KitMARCAINE, LIDOCAINE, POVIDONE IODINEAdvanced Rx of Tennessee, LLC49ef92f6-54d0-3d47-e063-6394a90aacec2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797730
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
First Aid AntisepticFIRST AID ANTISEPTICAmerisource Bergen6719db46-a6e3-4f0a-828c-fe89a51879892026-01-29Warnings, Adverse reactionsExact identifier
unii: 85H0HZU99M
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
MedlinePOVIDONE-IODINEMedline Industries, LP48ebfdd6-d346-7e26-e063-6394a90af11a2026-01-23WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M
EVERLIT SURVIVAL IODINE PREP PADSPOVIDONE-IODINEEVERLIT GLOBAL INC.3a03fc8d-2653-9183-e063-6294a90ad76e2026-01-23WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M
Lights Povindone Iodine SwabstickPOVIDONE-IODINELights Medical Manufacture Co., Ltd.977b6077-bf47-4e02-bde4-c752e73d76282026-01-21WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M
Lights Povindone Iodine ScrubPOVIDONE-IODINELights Medical Manufacture Co., Ltd.000bf57b-1805-4746-bf1c-32856241213a2026-01-21WarningsExact identifier
unii: 85H0HZU99M
Lights Povidone Iodine SolutionPOVIDONE-IODINELights Medical Manufacture Co., Ltd.6946eb98-6870-4b21-9dda-b01a8adab84b2026-01-21WarningsExact identifier
unii: 85H0HZU99M
Lights Povidone Iodine Prep PadPOVIDONE-IODINELights Medical Manufacture Co., Ltd.e561332d-e419-43db-a68e-0c0d49b01c9a2026-01-21WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M
Lights Povindone Iodine SwabstickPOVIDONE-IODINELights Medical Manufacture Co., Ltd.2610fde4-4572-4d15-a970-f6d3beb734fe2026-01-21WarningsExact identifier
unii: 85H0HZU99M
Lights Povidone Iodine SolutionPOVIDONE-IODINELights Medical Manufacture Co., Ltd.7d4a92be-0601-4256-bc5b-bc1b07d97bb72026-01-21WarningsExact identifier
unii: 85H0HZU99M
Betadine GarglePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.5f0a3377-1398-2603-c632-f0d214bb88ec2026-01-21WarningsExact identifier
unii: 85H0HZU99M
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1b1e224c-8c00-46ea-9bdd-020a9b45321d2026-01-21WarningsExact identifier
unii: 85H0HZU99M
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Maokang Povidone-Iodine ScrubPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd5f945e64-aee7-4b68-ad8b-9c8d4875842a2026-01-20WarningsExact identifier
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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