FDA.reportPublic FDA data

NDC 55553-449 - ACL5SPG 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
55553-449
Package NDCs from labels
55553-449-02
Manufacturer
Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.
Effective date
2013-02-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACL5SPG SINGLE SHOT EPIDURALClint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.2013-02-12MEDICAL DEVICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4713-65ACL5SPG SINGLE SHOT EPIDURAL5 mL in 1 AMPULEINJECTION, SOLUTION5 mL10 mg in 1mL2
55553-449-02ACL5SPG SINGLE SHOT EPIDURAL1 in 1 PACKAGE, COMBINATIONKIT12
55553-449-02ACL5SPG SINGLE SHOT EPIDURAL30 in 1 CASEKIT302
65282-1510-1ACL5SPG SINGLE SHOT EPIDURAL10 mL in 1 AMPULESOLUTION10 mL9 mg in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55553-449ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]24 package rows20130220_51586daa-df26-4242-b970-c7d29fe30660.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
CHLORIDE IONACTIVE MOIETYQ32ZN48698ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
IODINEACTIVE MOIETY9679TC07X4ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
LidocaineACTIVE MOIETY98PI200987ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RACL5SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2

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 54 of 71 · 1,417 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC037ac04d-f8f3-4bb8-993a-ac8f7683ff832024-01-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
Povidone IodinePOVIDONE IODINE 10%Pharma Nobis, LLCe42eee1b-3539-fb17-e053-2995a90af61d2023-12-22WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Pharma Nobis, LLCe42ee827-b350-7b56-e053-2a95a90a69cf2023-12-22WarningsExact identifier
unii: 85H0HZU99M
Quality Choice Povidone IodinePOVIDONE IODINE 10%Chain Drug Market Association9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d2023-12-20WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Premier Value Povidone IodinePOVIDONE IODINE 10%Chain Drug Consortium5cc9d782-5f7e-27d9-e053-2991aa0a24282023-12-20WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
CVS Povidone-IodinePOVIDONE IODINECVS Pharmacy402d571f-e1e8-43fd-9e7b-05aab18379052023-12-20WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
sunmark Povidone-Iodine TopicalPOVIDONE-IODINEStrategic Sourcing Services LLCacc349d6-2875-4814-aa6e-828fffec7f072023-12-19WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
DDM Povidone IodinePOVIDONE IODINE 10%Discount Drug Mart5d161a9d-0462-0afd-e053-2991aa0a22e22023-12-19WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Sinus HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, THUJA OCCIDENTALISEnergique, Inc.3cdddbe5-e3d2-4629-a045-868e18183f1d2023-12-19WarningsExact identifier
unii: 451W47IQ8X
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
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Povidone-Iodine Prep SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdbb62784a-d7b7-471e-9aed-0c6d2e349c3a2023-12-13WarningsExact identifier
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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