FDA.reportPublic FDA data

NDC 55553-470 - ACL17SPG 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
55553-470
Package NDCs from labels
55553-470-02
Manufacturer
Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.
Effective date
2014-04-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACL17SPG SINGLE SHOT EPIDURALClint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.2014-04-07MEDICAL DEVICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55553-470-02ACL17SPG SINGLE SHOT EPIDURAL24 in 1 CASEKIT244
55553-470-02ACL17SPG SINGLE SHOT EPIDURAL1 in 1 PACKAGE, COMBINATIONKIT14
65282-1510-1ACL17SPG SINGLE SHOT EPIDURAL10 mL in 1 AMPULESOLUTION10 mL9 mg in 1mL4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55553-470ACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]43 package rows20140408_88f6e5e4-0179-41aa-854b-a148fe49fe58.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4
IODINEACTIVE MOIETY9679TC07X4ACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4
LidocaineACTIVE MOIETY98PI200987ACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4
SODIUM CATIONACTIVE MOIETYLYR4M0NH37ACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4
WaterINACTIVE INGREDIENT059QF0KO0RACL17SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]4

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 5 of 104 · 2,066 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspercreme Lidocaine No-Mess plus LavenderLIDOCAINE HCLChattem, Inc.3948a3d2-ce04-4703-8709-211e75c9c38d2026-07-29WarningsExact identifier
unii: V13007Z41A
Aspercreme Professional CreamLIDOCAINE HCL 4%Chattem, Inc.ef297864-5917-4645-8ec7-f2bc49e037e82026-07-29WarningsExact identifier
unii: V13007Z41A
Xylocaine MPFLIDOCAINE HYDROCHLORIDESportpharm LLC50aa6133-0776-4714-9821-fe8581f635ca2026-07-28Warnings, Adverse reactionsExact identifier
rxcui: 1737757
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEBenco Dental9419ac39-9b26-4cca-a2d6-167205fede242026-07-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dental6506755f-c9f7-4286-9ba7-ac5d5745f5e42026-07-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLC27e8fdfb-e923-4f99-aff7-8b9e502281512026-07-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLCe5ed4c2a-e320-48cf-a2fd-61d48481c6242026-07-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dentalf074c0dc-7c3f-46fd-a480-b8337a19fe5c2026-07-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
unii: V13007Z41A
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCa32cbc19-ec30-4634-b70d-664f2a2edd952026-07-24WarningsExact identifier
unii: V13007Z41A
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: V13007Z41A
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ALORYXAGYNECOLOGICAL INTIMATE CARE GELTupelo Brittany LLC57346a86-ab51-021a-e063-6394a90a1dc22026-07-22WarningsExact identifier
unii: 85H0HZU99M
First Aid AntisepticPOVIDONE-IODINE 5%Walgreen Company262ea2c8-f571-1c0b-e063-6394a90af20b2026-07-22WarningsExact identifier
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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