FDA.reportPublic FDA data

NDC 55553-474 - ACL20S 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
55553-474
Package NDCs from labels
55553-474-02
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
ACL20S 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
0409-4713-65ACL20S SINGLE SHOT EPIDURAL5 mL in 1 AMPULEINJECTION, SOLUTION5 mL10 mg in 1mL2
55553-474-02ACL20S SINGLE SHOT EPIDURAL1 in 1 PACKAGE, COMBINATIONKIT12
55553-474-02ACL20S SINGLE SHOT EPIDURAL30 in 1 CASEKIT302
65282-1510-1ACL20S 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
55553-474ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]24 package rows20130220_a8238514-87db-47b2-98e7-32f3e0c19ba5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
CHLORIDE IONACTIVE MOIETYQ32ZN48698ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
IODINEACTIVE MOIETY9679TC07X4ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
LidocaineACTIVE MOIETY98PI200987ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACL20S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RACL20S 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 25 of 106 · 2,108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexlido-M KitDEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, MARICAINE, POVIDINE IODINEAsclemed USA, Inc.d3fd1d51-7749-4e1e-a8b5-8a151392f66d2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1737568
Physician EZ Use Joint Tunnel and Trigger Kit IILIDOCAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINEAsclemed USA, Inc.0d2d52ef-ff21-4b28-b8ae-6a46570f7a742026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 1737568
MLK F4 KitTRIAMCINOLONE ACETONIDE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1737757
MLK F1 KitMARCAINE, LIDOCAINE, KENALOG, POVIDONE IODINEAsclemed USA, Inc.0cd42a2f-d202-447d-998e-8877ac3c0d382026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1737757
Marlido 25 KitLIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.1fe460e7-208d-410e-84c5-cd63005cff472026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1737568
Ketorocaine LM KitKETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.35ffe071-8bc1-4c88-8c85-645847acf1692026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1737568
Marbeta L KitBETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.9a6a3871-4e02-47f9-a20e-a256b3f3c4982026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1737566
MLK F3 KitMARCAINE, LIDOCAINE, KENALOG, POVIDONE IODINEAsclemed USA, Inc.481aeef5-01cb-4567-a67f-896e6929b2ed2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1737757
Dyural 80 KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOLAsclemed USA, Inc.e9f7f923-e7f9-4c52-b56d-914d800c1acf2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1737566
rxcui: 1807637
Lidolog KitLIDOCAINE, KENALOG, POVIDONE IODINEAsclemed USA, Inc.069e145d-7992-4f56-9fcb-20782ecc2d532026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 1737757
Dyural L KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.4879f990-e879-47e1-99bc-b4bfcb32bcff2026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 1737566
Multi-Specialty KitDEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.5f2768d1-90c4-4d73-902d-fc7a947da7a52026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 1737568
Ketorocaine L KitKETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.ee0d396c-5caa-4a1a-9865-1a742d9d8d682026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1737568
Dyural LM KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.cdd72141-10b6-48c6-85be-5b1294c8539c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1737566
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd125a49c3-15c0-fbad-e063-6394a90a5d2e2026-01-08WarningsExact identifier
unii: 85H0HZU99M
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd12585502-c043-6ffb-e063-6394a90a66022026-01-08WarningsExact identifier
unii: 85H0HZU99M
Burn Relief AloeLIDOCAINE HCLAcutens48c435fe-2670-4b80-bf01-923dc93544222026-01-08WarningsExact identifier
unii: V13007Z41A
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
unii: V13007Z41A
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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