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 19 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB Povidone IodinePOVIDONE IODINE 10%H E B5d576ce2-7d63-c860-e053-2a91aa0a072c2023-12-18WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Publix Povidone IodinePOVIDONE IODINE 10%Publix5d6bba46-2571-4957-e053-2a91aa0a2e852023-12-18WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
DermaWound Wound CarePOVIDONE-IODINEProgressive Doctors, LLC2d49daa7-aa02-4219-880b-e1697bde8a7e2023-12-15WarningsExact identifier
unii: 85H0HZU99M
Povidone IodinePOVIDONE-IODINE SPRAY 5%Humco Holding Group, Inc.a7bb80c4-bbc0-21ea-e053-2995a90a52c12023-12-15WarningsExact identifier
unii: 85H0HZU99M
Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.6064c23b-7c15-208d-e053-2991aa0a00f62023-12-15WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Humco Holding Group, Inc.a7b9ad55-cfeb-6066-e053-2a95a90af9752023-12-15WarningsExact identifier
unii: 85H0HZU99M
Povidone IodinePOVIDONE IODINE ORAL RINSE 0.5%Humco Holding Group, Inc.b83dbdd1-ff63-caf8-e053-2a95a90a57642023-12-15WarningsExact identifier
unii: 85H0HZU99M
Rite Aid Povidone IodinePOVIDONE IODINE 10%Rite Aid Corporation5df6ff37-a4ea-d666-e053-2991aa0a97862023-12-15WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Povidone-Iodine Prep SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdbb62784a-d7b7-471e-9aed-0c6d2e349c3a2023-12-13WarningsExact identifier
unii: 85H0HZU99M
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: 2968PHW8QP
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
PhexxiLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.173ff411-7227-47b0-94dc-844e1ebaf14e2023-11-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Prep non sterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdecbe037b-77da-4ffc-8c60-e56f428766af2023-11-15WarningsExact identifier
unii: 85H0HZU99M
Prep Pad SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd758abf53-ad8a-62ac-e053-2991aa0a8f0c2023-11-15WarningsExact identifier
unii: 85H0HZU99M
Maokang Povidone Iodine Swabsticks 3sPOVIDONE-IODINEChangzhou Maokang Medical Products Co.,Ltd15443c2d-b531-4635-8d0c-53057bee0db72023-11-14WarningsExact identifier
unii: 85H0HZU99M
TWO PVP-I SCRUB STICKSPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd88bee1c7-0d6d-46b7-8dce-ce05aa0388fa2023-11-10WarningsExact identifier
unii: 85H0HZU99M
TWO PVP-I SCRUB LARGE WINGED SPONGESPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd4295c0c5-6be0-4d0f-9456-a92e3571d6792023-11-10WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine Scrub SterilePOVIDONE-IODINECardinal Health 200 LLC66146848-aec8-466f-b993-6b8e3318165d2023-11-10WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine Prep SterilePOVIDONE-IODINECardinal Health 200 LLCafc2b2c2-046b-4319-b0b8-cf6d7a74b5f62023-11-10WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine Prep Winged Sterile LargePOVIDONE-IODINECardinal Health 200, Inc1a19eee2-d023-4fca-9564-d49b45fe656f2023-11-10WarningsExact identifier
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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