NDC 55553-462 - ACS25Q35F SPINAL

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
55553-462
Package NDCs from labels
55553-462-02
Manufacturer
Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc.
Effective date
2012-06-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IODINE - Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc.Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc.2012-06-27MEDICAL DEVICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-0001-3ACS25Q35F SPINAL22.5 mL in 1 PACKETSOLUTION22.5 mL0.10 mg in 1mL4
55553-462-02ACS25Q35F SPINAL1 in 1 PACKAGE, COMBINATIONKIT14
55553-462-02ACS25Q35F SPINAL30 in 1 CASEKIT304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55553-462ACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]43 package rows20120716_98d482f0-070a-42d3-af48-0c189d4b2f8d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4
IODINEACTIVE MOIETY9679TC07X4ACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4

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 20 of 25 · 481 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone-Iodine Prep SterilePOVIDONE-IODINECardinal Health 200, Incb123606d-b131-466a-ab20-9dded97bb5a12023-11-10WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine Prep SterilePOVIDONE-IODINECardinal Health 200 LLC6f5ac6b5-389d-473b-8398-176e48adc1b52023-11-10WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine Prep Winged Sterile SmallPOVIDONE-IODINECardinal Health 200 LLC7583ebae-a272-498a-9654-ecaa8e2866432023-11-10WarningsExact identifier
unii: 85H0HZU99M
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
rxcui: 312564
unii: 85H0HZU99M
MK Povidone Iodine Swabstick SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd30de3868-f7d2-4674-a6c3-54a8d4ca61f02023-11-09WarningsExact identifier
unii: 85H0HZU99M
MK Povidone-Iodine Swabstick SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd563e88b9-9cd5-6751-e054-00144ff88e882023-11-09WarningsExact identifier
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
rxcui: 312564
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
unii: 85H0HZU99M
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
rxcui: 312564
unii: 85H0HZU99M
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltd0bd3de76-b726-41f1-87bc-14ab8a1eca8e2023-10-23WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0c0-030a-e054-00144ff88e882023-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0af-030a-e054-00144ff88e882023-10-23WarningsExact identifier
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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