FDA.reportPublic FDA data

NDC 55553-453 - ACL6SPG 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
55553-453
Package NDCs from labels
55553-453-02
Manufacturer
Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.
Effective date
2013-02-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACL6SPG SINGLE SHOT EPIDURALClint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.2013-02-13MEDICAL DEVICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4713-65ACL6SPG SINGLE SHOT EPIDURAL5 mL in 1 AMPULEINJECTION, SOLUTION5 mL10 mg in 1mL2
55553-453-02ACL6SPG SINGLE SHOT EPIDURAL1 in 1 PACKAGE, COMBINATIONKIT12
55553-453-02ACL6SPG SINGLE SHOT EPIDURAL24 in 1 CASEKIT242
65282-1510-1ACL6SPG 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
55553-453ACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]24 package rows20130220_554b59ff-7342-43a6-84a2-d97dd2c3426d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
CHLORIDE IONACTIVE MOIETYQ32ZN48698ACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
IODINEACTIVE MOIETY9679TC07X4ACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
LidocaineACTIVE MOIETY98PI200987ACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RACL6SPG 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 30 of 74 · 1,471 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSHenry Schein, Inc.a5d4b206-cc53-470f-9bca-abfc6ea5cc992025-09-29Warnings, Adverse reactionsExact identifier
application number: ANDA080408
rxcui: 1737568
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
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: 451W47IQ8X
Saline LaxativeSALINE LAXATIVEMajor Pharmaceuticalsb3758ffe-1bac-4df6-9714-5e33e9d28d902025-09-16WarningsExact identifier
unii: GR686LBA74
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: 451W47IQ8X
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
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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