FDA.reportPublic FDA data

NDC 55553-478 - ACL10SPSL12 SINGLE SHOT EPIDURAL

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
55553-478
Package NDCs from labels
55553-478-02
Manufacturer
Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc.
Effective date
2012-09-07
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.2012-09-07MEDICAL DEVICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-0001-3ACL10SPSL12 SINGLE SHOT EPIDURAL22.5 mL in 1 PACKETSOLUTION22.5 mL0.10 mg in 1mL1
55553-478-02ACL10SPSL12 SINGLE SHOT EPIDURAL30 in 1 CASEKIT301
55553-478-02ACL10SPSL12 SINGLE SHOT EPIDURAL1 in 1 PACKAGE, COMBINATIONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55553-478ACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]13 package rows20120911_3344ac69-fa69-4f91-ae08-b875574e6b08.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]1
IODINEACTIVE MOIETY9679TC07X4ACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]1

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 17 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
SwabPOVIDONE-IODINEMcKesson Medical-Surgical Inc.4777b5f4-1698-08da-e054-00144ff8d46c2024-10-14WarningsExact identifier
unii: 85H0HZU99M
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Antiseptic Povidone-lodine Prep PadPOVIDONE-IODINEHubei Changjian Medical Products Co., Ltd.2cacf2e0-0192-4e0f-88a6-e3eee3af54712024-10-11WarningsExact identifier
unii: 85H0HZU99M
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltdc1862529-e8d8-4440-a043-38c01079ee8a2024-09-11WarningsExact identifier
unii: 85H0HZU99M
First Aid Only Povidone-Iodine AntisepticPOVIDONE-IODINEAcme United Corporatione0052ac2-4f74-32a4-e053-2995a90a94c62024-08-13WarningsExact identifier
unii: 85H0HZU99M
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Maokang Medical 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd644e92c3-3043-4a76-9845-7e0482cf9f622024-07-19WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
MedlinePOVIDONE-IODINEMedline Industries, LP11fd1661-1b8c-b65b-e063-6394a90af89b2024-07-01WarningsExact identifier
unii: 85H0HZU99M
Maokang Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdb3b885b6-5278-491f-ae75-8b7032fcccd82024-06-26WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 2968PHW8QP
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADI Medical PVP-I Pouch, FoilPOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0e8baf24-0c67-5511-e063-6394a90acaa12024-05-02WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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