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 8 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AplicarePOVIDONE IODINEAplicare Products LLC0b3e4f14-e9e6-2f2e-e063-6394a90ab2e12025-12-18WarningsExact identifier
unii: 85H0HZU99M
Aplicare Povidone-IodinePOVIDONE-IODINEAplicare Products, LLC1ad9237e-80ee-4769-ba53-9bc1bb6672492025-12-18WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Povidone IodinePOVIDONE-IODINETwinMed LLCfc8cb10c-4973-c0bd-e053-6394a90a6fdb2025-12-18WarningsExact identifier
unii: 85H0HZU99M
Povidone IodinePOVIDONE-IODINETwinMed LLCfcf27cbf-9535-1356-e053-6394a90a03622025-12-18WarningsExact identifier
unii: 85H0HZU99M
Povidone IodinePOVIDONE-IODINETwinMed LLCfcf30b3a-c25b-7aaf-e053-6394a90affda2025-12-18WarningsExact identifier
unii: 85H0HZU99M
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: 2968PHW8QP
VCF CONTRACEPTIVENONOXYNOL-9APOTHECUS PHARMACEUTICAL CORP.92f8eee8-2456-4baf-a85e-1335c80d7fcd2025-12-12WarningsExact identifier
unii: 48Q180SH9T
VCF CONTRACEPTIVE PRE-FILLED APPLICATORSNONOXYNOL-9APOTHECUS PHARMACEUTICAL CORP34be97cd-3646-427d-8112-ba0030ff8d882025-12-12WarningsExact identifier
unii: 48Q180SH9T
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
PaxLyteLEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULEJaymac Pharmaceuticalsf520b130-61b3-443e-aaf6-91e094e7a3342025-12-08Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
BD E-Z SCRUBPOVIDONE-IODINEBecton Dickinson and Companybc23c292-80cd-4211-b627-2e9984a945262025-12-08WarningsExact identifier
unii: 85H0HZU99M
PHARMA CARE Pro Sterile Prep Swabstick POVIDONE-IODINEPOVIDONE-IODINEEnviro Specialty Chemicals Inc915a96fe-e807-4697-9d50-b6b8af0858272025-12-04WarningsExact identifier
unii: 85H0HZU99M
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 2968PHW8QP
PROHEAL POVIDONE IODINE SWABSTICKPOVIDONE-IODINEClick Industries LLC974e1205-01ab-4599-9229-cdf5225d268a2025-12-03WarningsExact identifier
unii: 85H0HZU99M
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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