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 10 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Povidone Iodine PrepPOVIDONE IODINEPHOENIX HEALTHCARE SOLUTIONS, LLCc17603f2-3548-4225-b611-216c2763e51f2025-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine Prep SwabstickPOVIDONE IODINEPHOENIX HEALTHCARE SOLUTIONS, LLC8a0aba34-3f96-46b6-8521-f4388fb73edf2025-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine Prep Pads MediumPOVIDONE-IODINEMedline Industries, LP28c05c5c-09d3-2c62-e054-00144ff8d46c2025-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine Swabsticks SinglesPOVIDONE-IODINEMedline Industries, LP28c26a44-0699-4fa5-e054-00144ff88e882025-10-23WarningsExact identifier
unii: 85H0HZU99M
PROHEAL POVIDONE IODINE PREP PADSPOVIDONE-IODINEClick Industries LLC53733b6c-fa62-43e0-bfcc-3d23b5e1a95a2025-10-23WarningsExact identifier
unii: 85H0HZU99M
POVIDONE-IODINEPOVIDONE-IODINEJames Alexander Corporation181a6363-2249-45f0-a28b-79f2c5ffad592025-10-23WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Povidone-IodinePOVIDONE-IODINEMedline Industries, LP2b95078e-2caf-7005-e054-00144ff88e882025-10-22WarningsExact identifier
unii: 85H0HZU99M
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
equate First Aid AntisepticPOVIDONE-IODINEWalmart Inc.43bbedec-be30-482a-8552-949b13d4bea12025-10-14WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
MediChoice Povidone-Iodine Prep PadPOVIDONE-IODINEO&M HALYARD, INC.00bfdd07-af21-4b01-81fb-c89deea332882025-10-09WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine PrepPOVIDONE-IODINEO&M HALYARD, INC.f3e0af11-39b6-44a0-8f84-a4b36631e8f02025-10-09WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
MediChoice PVPPOVIDONE-IODINEO&M HALYARD, INC.04e9b3e7-2505-48c4-96a5-eb8eb2d1625e2025-10-09WarningsExact identifier
unii: 85H0HZU99M
MediChoice PVPPOVIDONE-IODINEO&M HALYARD, INC.63c6d510-5869-4416-96b9-5c4fb27e8c362025-10-09WarningsExact identifier
unii: 85H0HZU99M
MediChoice Povidone-IodinePOVIDONE-IODINEO&M HALYARD, INC.959332db-d522-450b-b09e-be6a998899db2025-10-09WarningsExact identifier
unii: 85H0HZU99M
MediChoice PVP PrepPOVIDONE-IODINEO&M HALYARD, INC.141c3490-3f50-9246-e063-6394a90a553c2025-10-09WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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