FDA.reportPublic FDA data

NDC 55553-453 - ACL6SPG 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
55553-453
Package NDCs from labels
55553-453-02
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
ACL6SPG 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
0409-4713-65ACL6SPG SINGLE SHOT EPIDURAL5 mL in 1 AMPULEINJECTION, SOLUTION5 mL10 mg in 1mL2
55553-453-02ACL6SPG SINGLE SHOT EPIDURAL1 in 1 PACKAGE, COMBINATIONKIT12
55553-453-02ACL6SPG SINGLE SHOT EPIDURAL24 in 1 CASEKIT242
65282-1510-1ACL6SPG 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
55553-453ACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]24 package rows20130220_554b59ff-7342-43a6-84a2-d97dd2c3426d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
CHLORIDE IONACTIVE MOIETYQ32ZN48698ACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
IODINEACTIVE MOIETY9679TC07X4ACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
LidocaineACTIVE MOIETY98PI200987ACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACL6SPG SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RACL6SPG 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 44 of 71 · 1,417 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maokang 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd7c17ce40-0358-44ff-aa60-53711666914b2024-11-21WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine SwabsticksPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltddde2c33c-c6e0-4339-ac3b-f40cc187105e2024-11-21WarningsExact identifier
unii: 85H0HZU99M
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC31df570a-35ae-41a2-b04a-fce65e9d596d2024-11-21WarningsExact identifier
unii: 85H0HZU99M
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC3dc3303f-54b2-4aec-8568-5e0f8eb7cb142024-11-21WarningsExact identifier
unii: 85H0HZU99M
Dynarex Povidone Iodine Prep SolutionPOVIDONE IODINE PREP SOLUTIONDynarex Corporation6bb4d55b-2be7-3549-e053-2a91aa0a2bb02024-11-20WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Dynarex Povidone Iodine Surgical ScrubPOVIDONE IODINE SURGICAL SCRUB SOLUTIONDynarex Corporation6f053e55-cbf6-9072-e053-2991aa0a2edd2024-11-20WarningsExact identifier
unii: 85H0HZU99M
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation37063a49-6b45-4167-875d-49c9dac3f79b2024-11-20WarningsExact identifier
unii: 451W47IQ8X
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMLeosons Overseas Corp90e7c2b4-35e1-4a27-afea-9257c480e1902024-11-19WarningsExact identifier
unii: GR686LBA74
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharmace42122f-8087-471f-b0a3-5524bdbd45262024-11-19Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Saninta 10% Povidone-IodinePOVIDONE-IODINE SOLUTIONLernapharm1275efa3-0602-2f17-e063-6394a90ac56e2024-11-15WarningsExact identifier
unii: 85H0HZU99M
XYLOCAINE MPFLIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst199ac3eb-1fa5-9cf5-e063-6394a90a72282024-11-15Warnings, Adverse reactionsExact identifier
rxcui: 1737566
unii: EC2CNF7XFP
TRICITRATESPOTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharma2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad2024-11-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Sal de Uvas PicotCITRIC ACID MONOHYDRATE AND SODIUM BICARBONATERB Health Mexico, S.A. de C.V.151b9bc9-1a6e-4401-ae58-4b4210ab45052024-11-15WarningsExact identifier
unii: 2968PHW8QP
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company99a15716-bbb9-4e33-a48d-20c58b81f3922024-11-13Exact identifier
unii: 451W47IQ8X
Itch FormulaANTIPYRINUM, APIS MELLIFICA, CALENDULA OFFICINALIS, CANTHARIS, COPAIVA OFFICINALIS, CROTON TIGLIUM, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, MEZEREUM, NATRUM MURIATICUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, SULPHUR, URTICA URENSDeseret Biologicals, Inc.4dfb177b-bff3-4b6d-8fd9-cadd1df7812c2024-11-12WarningsExact identifier
unii: 451W47IQ8X
First Aid Only Povidone-Iodine Prep PadPOVIDONE-IODINEAcme United Corporation509b6c8e-6a9f-2656-e054-00144ff8d46c2024-11-09WarningsExact identifier
unii: 85H0HZU99M
Plasma-Lyte 148 (pH 7.4)SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDEBaxter Healthcare Corporationfe935c8d-f42d-42e4-8665-0dc66829f2312024-11-08Exact identifier
unii: 451W47IQ8X
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYd3f90d2f-4536-4d32-800b-7a798f8a35db2024-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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