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 11 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MediChoice PVP Prep SolutionPOVIDONE-IODINEO&M HALYARD, INC.141c3490-3f52-9246-e063-6394a90a553c2025-10-09WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
MediChoice PVP PrepPOVIDONE-IODINEO&M HALYARD, INC.141c464f-a1ef-96d3-e063-6394a90a96a02025-10-09WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
MediChoice PVP ScrubPOVIDONE-IODINEO&M HALYARD, INC.141c539d-2cf2-0b7d-e063-6294a90ae5a92025-10-09WarningsExact identifier
unii: 85H0HZU99M
PurPrepPOVIDONE IODINE AND ISOPROPYL ALCOHOLCareFusion 213 LLCa1c6e118-7861-c8d0-e053-2995a90aeaaa2025-10-08WarningsExact identifier
unii: 85H0HZU99M
MediChoice PVP SwabsticksPOVIDONE-IODINEO&M HALYARD, INC.c1533687-4c45-4be3-9166-1c6bec69dcfe2025-10-08WarningsExact identifier
unii: 85H0HZU99M
MediChoice PVP SwabsticksPOVIDONE-IODINEO&M HALYARD, INC.433dacca-74a4-4f93-805e-829fb678752b2025-10-08WarningsExact identifier
unii: 85H0HZU99M
povidone-iodine 10%POVIDONE-IODINEBIONPHARMA INC.3e63514a-dbb8-5bef-e063-6294a90a40082025-10-06WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Profend Nasal DecolonizationPOVIDONE IODINE USP, 10% W/WProfessional Disposables International, Inc.6245b1e5-6637-18bc-e053-2a91aa0aa9812025-10-02WarningsExact identifier
unii: 85H0HZU99M
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Leader Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMCardinal Health1b4f9c28-0547-4922-aa15-990c6fd9dc9f2025-09-29WarningsExact identifier
unii: GR686LBA74
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Care27c29a33-d1cc-d72f-e063-6394a90a4d452025-09-19WarningsExact identifier
unii: 85H0HZU99M
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Caref5252b4f-5e14-509e-e053-2995a90a6db82025-09-18WarningsExact identifier
unii: 85H0HZU99M
Saline LaxativeSALINE LAXATIVEMajor Pharmaceuticalsb3758ffe-1bac-4df6-9714-5e33e9d28d902025-09-16WarningsExact identifier
unii: GR686LBA74
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First PVP Iodine WipesPOVIDONE IODINE 10%Unifirst-First Aid406b4a37-816a-5ea4-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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