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 7 of 37 · 728 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid AntisepticPOVIDONE-IODINEBetter Living Brands, LLC3ce6e6af-b513-ed9f-e063-6394a90a4ce72026-02-23Warnings, Adverse reactionsExact identifier
unii: 85H0HZU99M
Maokang Povidone-Iodine AntisepticPOVIDONE-IODINEChangzhou Maokang Medical Products Coef5c04a5-e4d4-493c-a0e6-625d2d19d1b02026-02-23WarningsExact identifier
unii: 85H0HZU99M
Maokang Povidone-Iodine AntisepticPOVIDONE-IODINEChangzhou Maokang Medical Products Co5791213f-9cc1-429d-83fa-bb6611f7fc692026-02-23WarningsExact identifier
unii: 85H0HZU99M
Konix Povidone Iodine Topical AntisepticPOVIDONE-IODINETURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS0cc6b001-4982-40ee-a476-151f86c14a8e2026-02-19WarningsExact identifier
unii: 85H0HZU99M
First Aid AntisepticPOVIDONE-IODINEMeijer, Inc.193292da-390b-4430-91b1-1d159ac505072026-02-19Warnings, Adverse reactionsExact identifier
unii: 85H0HZU99M
First Aid AntisepticPOVIDONE-IODINETarget Corporation78693ec1-d725-408c-bb95-2261faad84ac2026-02-18Warnings, Adverse reactionsExact identifier
unii: 85H0HZU99M
Povidone-Iodine SwabstickPOVIDONE IODINEProfessional Disposables International, Inc.31d08e09-181b-3a7a-e063-6294a90aa7572026-02-17WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M
Konix Povidone Iodine Topical AntisepticPOVIDONE-IODINETURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS8a9848b0-19df-455a-9984-5ea2e5ce1b9f2026-02-17WarningsExact identifier
unii: 85H0HZU99M
First Aid AntisepticPOVIDONE-IODINETopco Associates LLCe258fbd2-f1dd-4ba0-ac9b-64246f2db50b2026-02-13Warnings, Adverse reactionsExact identifier
unii: 85H0HZU99M
First Aid AntisepticPOVIDONE-IODINEWalgreen Co.b1c71ff1-8ffa-46df-9b43-86ed062c3a982026-02-12Warnings, Adverse reactionsExact identifier
unii: 85H0HZU99M
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Povidone Iodine Prep PadPOVIDONE IODINE PREP PADHua Jing Medical Supplies INC.4a65fe55-e870-2576-e063-6294a90ae9292026-02-10WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
EVERLIT CARE PRODUCTS IODINE PREP PADPOVIDONE-IODINEEVERLIT GLOBAL INC.5cbdb73d-333a-4244-a1c0-be430632f0ed2026-02-09WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M
MedlinePOVIDONE-IODINEMedline Industries, LP494d7e97-a3a8-2c7a-e063-6394a90a3ae12026-02-02WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
unii: PDC6A3C0OX
First Aid AntisepticPOVIDONE-IODINERite Aid Corporation2f8abb6f-460f-47bf-811d-734126aa3f0b2026-01-30Warnings, Adverse reactionsExact identifier
unii: 85H0HZU99M
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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