FDA.reportPublic FDA data

NDC 55553-445 - ACL4SP 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
55553-445
Package NDCs from labels
55553-445-02
Manufacturer
Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc.
Effective date
2015-04-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IODINE - Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc.Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc.2015-04-01MEDICAL DEVICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55553-445-02ACL4SP SINGLE SHOT EPIDURAL1 in 1 PACKAGE, COMBINATIONKIT13
55553-445-02ACL4SP SINGLE SHOT EPIDURAL30 in 1 CASEKIT303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55553-445ACL4SP SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]32 package rows20150402_d0a1d386-1fa0-47f5-9ca3-2cd55501d282.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MACL4SP SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]3
IODINEACTIVE MOIETY9679TC07X4ACL4SP SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACL4SP SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]3
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TACL4SP SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACL4SP SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACL4SP SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RACL4SP SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]3

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 2 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
unii: 85H0HZU99M
Aplicare Povidone-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCff19ea2f-d6a0-442f-8f23-d559fc13c5492026-07-14WarningsExact identifier
unii: 85H0HZU99M
MedlinePOVIDONE-IODINEMedline Industries, LP1d731a44-f16e-c249-e063-6294a90a39b82026-07-08WarningsExact identifier
unii: 85H0HZU99M
Povidone-IodinePOVIDONE-IODINECARDINAL HEALTH 110, LLC. DBA LEADER4f0d8da5-a75b-acc7-e063-6394a90ae8392026-07-08WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 2968PHW8QP
CVS Povidone IodinePOVIDONE IODINECVS Pharmacy Inca8d754f4-a696-d0d9-e053-2a95a90a4aff2026-06-24WarningsExact identifier
unii: 85H0HZU99M
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Swab Applicator Brushes Iodine (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w)IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD54e83df5-bbeb-d068-e063-6394a90ad5132026-06-23WarningsExact identifier
unii: 85H0HZU99M
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
PVP-I Prep PadPOVIDONE-IODINEProfessional Disposables International, Inc.57b02fbb-a9a6-0b8c-e063-6394a90a44f32026-06-22WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine Scrub SolutionPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdefa7f9f6-ae02-4104-bb9e-16e1ffd2be7a2026-06-17WarningsExact identifier
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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