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 4 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid AntisepticPOVIDONE-IODINERetail Business Services, LLCad4e49b6-5784-4880-950b-6e6175fc312b2026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 312564
unii: 85H0HZU99M
3M Skin and Nasal AntisepticPOVIDONE-IODINESolventum US LLC1a94494d-7dd3-4f32-bc42-81c199fe233e2026-04-22WarningsExact identifier
unii: 85H0HZU99M
Freskaro Povidone IodinePOVIDONE IODINE 10%Pharma Nobis, LLC4f711d3b-5ed6-5dd4-e063-6294a90afeaa2026-04-14WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Povidone Iodine 10%POVIDONE IODINEFarmacias De Similares TX LLC4e6baed0-ea31-79e2-e063-6294a90a3bb12026-04-01WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Povidone Iodine Prep PadANTISEPTICDynarex Corporation81b475e8-8da4-7b15-e053-2991aa0a66292026-03-25WarningsExact identifier
unii: 85H0HZU99M
povidine iodinePOVIDINE IODINEDynarex Corporation564ec54b-353e-45a8-85e8-a39f89488d9c2026-03-23WarningsExact identifier
unii: 85H0HZU99M
First Aid AntisepticPOVIDONE-IODINEAmazon.com Services LLC3e2b255c-e3b7-468c-9ac1-b63279c5ac7f2026-03-20Warnings, Adverse reactionsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Profend Nasal Antiseptic KitPOVIDONE IODINE USP, 10% W/WProfessional Disposables International, Inc.3eeddd1d-7190-b35c-e063-6394a90ae8162026-03-18WarningsExact identifier
unii: 85H0HZU99M
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
First Aid AntisepticPOVIDONE-IODINEOld East Main Co.fb9bbb51-d131-42b4-94e6-b752595b10812026-03-02WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
First Aid AntisepticPOVIDONE-IODINEWalmart Inc.c8fa5ed3-0497-4a23-934b-c72ff02c94ae2026-02-27Warnings, Adverse reactionsExact identifier
rxcui: 312564
unii: 85H0HZU99M
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Lightning X POVIDONE IODINE WIPEPOVIDONE IODINE WIPEChangzhou Maokang Medical Products Co., Ltd.04be4c2f-742b-7058-e063-6394a90a460d2026-02-25WarningsExact identifier
unii: 85H0HZU99M
First Aid AntisepticPOVIDONE-IODINEFamily Dollar Stores, Inc58157bc5-54ea-49f8-9f17-f0eeb57323952026-02-24Warnings, Adverse reactionsExact identifier
rxcui: 312564
unii: 85H0HZU99M
First Aid AntisepticPOVIDONE-IODINEBetter Living Brands, LLC3ce6e6af-b513-ed9f-e063-6394a90a4ce72026-02-23Warnings, Adverse reactionsExact identifier
rxcui: 312564
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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