FDA.reportPublic FDA data

NDC 55553-472 - ACL18S 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
55553-472
Package NDCs from labels
55553-472-02
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
ACL18S 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
0409-4713-65ACL18S SINGLE SHOT EPIDURAL5 mL in 1 AMPULEINJECTION, SOLUTION5 mL10 mg in 1mL2
55553-472-02ACL18S SINGLE SHOT EPIDURAL30 in 1 CASEKIT302
55553-472-02ACL18S SINGLE SHOT EPIDURAL1 in 1 PACKAGE, COMBINATIONKIT12
65282-1510-1ACL18S 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
55553-472ACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]24 package rows20130220_ac586e55-53bb-405e-8153-8c9090d9bc29.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
CHLORIDE IONACTIVE MOIETYQ32ZN48698ACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
IODINEACTIVE MOIETY9679TC07X4ACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
LidocaineACTIVE MOIETY98PI200987ACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACL18S SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RACL18S 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 17 of 74 · 1,471 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
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
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
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
Povidone IodinePOVIDONE-IODINESion Biotext Medical Ltd3ef9a05b-e434-4f6d-94a1-94aa6723fe8f2026-01-08WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine Gel SwabstickPOVIDONE IODINE GEL SWABSTICKSion Biotext Medical Ltd1058b4ff-c337-7a5a-e063-6394a90aca412026-01-08WarningsExact identifier
unii: 85H0HZU99M
Anti-Constipation Drops 2077ANTI-CONSTIPATION DROPSProfessional Complementary Health Formulas55d105fe-5698-43a6-9252-eaa9b63299d02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anxious Drops 2098ANXIOUS DROPSProfessional Complementary Health Formulasa5dc8619-074a-4c1f-8bb2-fea788f5aff12026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus Liquescence 3023SPLEEN THYMUS LIQUESCENCEProfessional Complementary Health Formulasabe3c5c4-c5b4-47dd-afe3-b7858c82f7752026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Bladder 7006RET BLADDERProfessional Complementary Health Formulasf1d354e7-3d72-40aa-aaf1-172cb39f07112026-01-08WarningsExact identifier
unii: 451W47IQ8X
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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