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 32 of 37 · 724 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone-Iodine Scrub SterilePOVIDONE-IODINECardinal Health 200, Incc1cdc3d3-e02a-42fb-9cb2-6a1b56a3c6072023-11-10WarningsExact identifier
unii: 85H0HZU99M
Moakang Povidone-Iodine Scrub Winged SpongesPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdc01deba5-7d93-41db-ac45-5df1f5664aff2023-11-09WarningsExact identifier
unii: 85H0HZU99M
MK Povidone Iodine Swabstick SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd30de3868-f7d2-4674-a6c3-54a8d4ca61f02023-11-09WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M
MK Povidone-Iodine Swabstick SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd563e88b9-9cd5-6751-e054-00144ff88e882023-11-09WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M
Surgical Scrub Skin CleanserPOVIDONE-IODINEDegasa SA De CV6226f403-a193-4664-aa78-8a7bd168c5192023-11-05WarningsExact identifier
unii: 85H0HZU99M
Prep Solution Topical Antiseptic MicrobicidePOVIDONE-IODINEDegasa SA De CVdd34cc57-8a8c-4189-b517-61448f961c9e2023-11-05WarningsExact identifier
unii: 85H0HZU99M
Antiseptic Patient Preoperative Skin Preparation and Surgical Hand ScrubPOVIDONE-IODINEDegasa SA De CV90a228bc-f380-4bc6-ae65-957c66e59b3c2023-11-05WarningsExact identifier
unii: 85H0HZU99M
Povidone IodinePOVIDONE-IODINEDr Radows58e1757c-45ce-455e-bd64-a9e99cd3680f2023-10-30WarningsExact identifier
unii: 85H0HZU99M
POVIDONE-IODINE PAD- povidone-iodine swabPOVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)Raya Pharmaceuticals LLCdbcbd1be-5274-3de3-e053-2995a90abf1c2023-10-27WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M
Family WellnessGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUMFRONT PHARMACEUTICAL PLCeb1785f4-5876-443b-b175-9b59d65d1a482023-10-26WarningsExact identifier
unii: PDC6A3C0OX
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
unii: PDC6A3C0OX
Family WellnessGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUMZhejiang Jingwei Pharmaceutical Co., Ltd.fde9cd90-d63c-4058-b46e-511fecea36ec2023-10-24WarningsExact identifier
unii: PDC6A3C0OX
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltde1789944-3a41-4c86-b173-3a6993ae21412023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltd14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d2023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltdb82cea56-b09f-411d-a6cf-c53b3ce0e3b62023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd78131b57-1ffc-4eb8-821e-f7bb73300fe92023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltdeb30e5de-9074-4760-8e92-e1d1c127227d2023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltd0bd3de76-b726-41f1-87bc-14ab8a1eca8e2023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0c0-030a-e054-00144ff88e882023-10-23WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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