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 47 of 106 · 2,108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.994cbc8e-a221-1548-e053-2995a90a1f7f2025-08-20WarningsExact identifier
unii: 451W47IQ8X
MedPride PrepPadsPOVIDONE IODINEShield Line LLC289e92a2-f03f-4b8a-e054-00144ff8d46c2025-08-19WarningsExact identifier
unii: 85H0HZU99M
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
unii: 2968PHW8QP
Jacksons Cell Salts NAT MUR 6X 9NATRUM MURIATICUMZettl Health Inc.3cbe47fc-db38-e6e9-e063-6294a90a3f1c2025-08-19WarningsExact identifier
unii: 451W47IQ8X
MedPride Povidone Iodine Scrub Solution Skin CleanserPOVIDONE-IODINEShield Line LLC88dfef39-c6c2-44fc-e053-2995a90a805a2025-08-18WarningsExact identifier
unii: 85H0HZU99M
MedPride Prep Solution Topical Antiseptic MicrobicidePOVIDONE-IODINEShield Line LLC88cb1b8d-3dae-be00-e053-2995a90a0d112025-08-18WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Ocean Potion Suncare Ice Plus Pain Relieving SoothingLIDOCAINEGNL BRANDS INTERNATIONAL, LLC3c69654c-cba6-dfef-e063-6394a90ad4792025-08-15WarningsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECintas First Aid & Safety96f17095-31f3-4b8a-ab22-0caaefaa74762025-08-15WarningsExact identifier
unii: V13007Z41A
BurnLIDOCAINEHART Healthc5ff392a-e788-43e0-91ea-5e0f8420586c2025-08-15WarningsExact identifier
unii: V13007Z41A
Signature Care Aloe Vera Gel with LidocaineLIDOCAINESafeway, Inc.d5069622-97b1-ba12-e053-2a95a90a72682025-08-14WarningsExact identifier
unii: V13007Z41A
Lidocaine 3%LIDOCAINE HCL 3%PureTek Corporation3bc94d52-fe52-9fd6-e063-6294a90a43402025-08-12WarningsExact identifier
unii: V13007Z41A
QUALITY CHOICE SALINESODIUM CHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f51491d8-12ad-4b1b-a171-c621bfdcc3412025-08-12WarningsExact identifier
unii: 451W47IQ8X
HealthWise Lidocaine CleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEVeridian Healthcare6022803a-097e-41c6-b9ee-48c8ef380d7a2025-08-12WarningsExact identifier
unii: V13007Z41A
Good Sense Pain Relief Roll OnLIDOCAINE HCLGeiss, Destin & Dunn, Inc38e76fd6-e5fb-493c-e063-6294a90afed42025-08-08WarningsExact identifier
unii: V13007Z41A
Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.e0466bb3-6c26-4044-b051-69f48b67f6322025-08-07Adverse reactionsExact identifier
rxcui: 1807637
unii: 451W47IQ8X
Aruba Aloe AlcoholadaLIDOCAINE HYDROCHLORIDEAruba Aloe Balm NVf56c62b0-75db-4499-858e-54e10b0e140a2025-08-07WarningsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDELannett Company, Inc.c3353e08-2a8c-4ace-ba89-114f7131b8de2025-08-07Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
XylocaineLIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE INJECTION, SOLUTIONHenry Schein, Inc9e8d0318-b2fe-4084-aedf-de97f61605a82025-08-07Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
Schuessler Tissue Salts Nat Mur Fluid Balance 9NATRUM MURIATICUMMartin & Pleasance Pty Ltd08da6353-9625-4e8f-8575-a2b49f5d2ac62025-08-04WarningsExact identifier
unii: 451W47IQ8X
Gout Relief 3310-SCELERY SEED, MEDICAGO SATIVA WHOLE,CHICORY ROOTBispit Canada Ltd.3afaa7d9-3de3-52d9-e063-6294a90a54ec2025-08-02WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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