FDA.reportPublic FDA data

NDC 55553-466 - ACL7SPG 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
55553-466
Package NDCs from labels
55553-466-02
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
ACL7SPG 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
0409-4713-65ACL7SPG SINGLE SHOT EPIDURAL5 mL in 1 AMPULEINJECTION, SOLUTION5 mL10 mg in 1mL2
55553-466-02ACL7SPG SINGLE SHOT EPIDURAL1 in 1 PACKAGE, COMBINATIONKIT12
55553-466-02ACL7SPG SINGLE SHOT EPIDURAL24 in 1 CASEKIT242
65282-1510-1ACL7SPG 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
55553-466ACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]24 package rows20130220_7b73e420-dffe-452d-968c-43f98d7d6af8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
CHLORIDE IONACTIVE MOIETYQ32ZN48698ACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
IODINEACTIVE MOIETY9679TC07X4ACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
LidocaineACTIVE MOIETY98PI200987ACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACL7SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RACL7SPG 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 26 of 71 · 1,417 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XylocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.cfcc8a07-b40c-476d-9a21-83487318ac852025-11-07Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.31188cdf-7bc8-4d78-bfaf-c1dc9f851fd42025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
XylocaineLIDOCAINE HYDROCHLORIDEHenry Schein, Inc.ffc87dfb-0e26-4b42-80fd-3fb7690119e32025-11-07Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
XylocaineLIDOCAINE HCLHenry Schein, Inc.a6019956-a6e0-4988-a870-6aee06c354c32025-11-07Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.d3d29c8f-c326-4097-814a-7f4e08c670682025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.01721071-af03-4894-95c1-10b8bc64b8882025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.190da07e-a616-46e6-b4e5-1c0ba39306e52025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.f6d82772-638c-4584-b9d3-8833669f59632025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Com-Pare2 Dual Yeast Relief Plus Multi-symptom FormulaCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, SULPHURTRP Company42b6b9b9-a673-0bba-e063-6394a90a88662025-11-03WarningsExact identifier
unii: 451W47IQ8X
Lidocaine Numbing CreamLIDOCAINE 5%YYBA Corp1319ee69-8b3f-5815-e063-6294a90a5ad52025-11-03WarningsExact identifier
unii: EC2CNF7XFP
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEICU Medical Inc.d8ee14e9-6733-4813-9f21-2b043a5f71882025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEICU Medical Inc.4555b1bf-6d97-4798-a63d-6d34291c85ce2025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.9dd1c001-73b3-41d4-9a96-61f6ad3a5dc32025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.3cfdeee0-ff14-4341-8396-b11c2a037c602025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.5f372b75-d7a4-471e-8ac6-290040fc84b02025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.243fe8fc-996a-4855-8daf-069628e547c42025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEICU Medical Inc.d310d170-5eeb-471b-af1a-0e845001d21d2025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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