FDA.reportPublic FDA data

NDC 51688-6440 - A4078-25 SPINAL 25G WHITACRE

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
51688-6440
Package NDCs from labels
51688-6440-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2020-03-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Povidone-Iodine - Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.2020-03-16MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8A4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
EPINEPHRINEACTIVE INGREDIENTYKH834O4BHA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
BUPIVACAINEACTIVE MOIETYY8335394ROA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
EPINEPHRINEACTIVE MOIETYYKH834O4BHA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
IODINEACTIVE MOIETY9679TC07X4A4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
LIDOCAINEACTIVE MOIETY98PI200987A4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74A4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RA4078-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, 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 93 of 100 · 1,987 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cardioplegic SolutionPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEFresenius Kabi, USA, LLCeb360dc4-88d6-4b28-9b61-bc359e16bd222022-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Stomach SaverABIES NIG, ANTIMON CRUD, ARG NIT, ARSENICUM ALB, CARBO VEG, CINCHONA, LYCOPODIUM, NAT PHOS, NUX MOSCH, NUX VOM, PODOPH PELT, ROBINIASilver Star Brandse0048c51-74e3-a7ff-e053-2995a90a1d412022-05-27WarningsExact identifier
unii: GR686LBA74
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDENovitium Pharma LLCffb2d794-2c88-48a2-beff-d01b6fcea51f2022-03-25Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Povidone-Iodine PadPOVIDONE-IODINEShandong Haiyan Medical Manufacture Co., Ltd.c9187a07-92d5-15ac-e053-2995a90af4cb2022-03-19WarningsExact identifier
unii: 85H0HZU99M
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.24a08a93-df23-474b-873e-c59ec8855f9f2022-03-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Wild Horse 777 Moisturizing NasalSODIUM CHLORIDEWild Horse 777, Inc.b0b4dadd-11fa-3dbb-e053-2995a90a20972022-03-14WarningsExact identifier
unii: 451W47IQ8X
Lydexa 4.12%LIDOCAINE HYDROCHLORIDEPureTek Corporationaa1c9d39-1283-8c6b-e053-2a95a90af5b52022-03-02Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.cc14fafd-3dcd-4fc8-bdbd-6f355c3757682022-02-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC8b44bfd3-70a4-4b47-bc7b-590f63b8cc752022-02-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCf62481fd-fcdb-4be6-ac13-29c590e925c32022-02-10Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.e44c41ae-c9c8-4dd8-ba6c-cebb585378aa2022-01-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist WalgreensSODIUM CHLORIDEWALGREEN COMPANYd6b9d4fc-b758-be32-e053-2995a90a25232022-01-29WarningsExact identifier
unii: 451W47IQ8X
Extra Strenght Saline Mist Rite AidSODIUM CHLORIDERITE AID CORPORATIONd5b30fb2-4052-4a0c-e053-2a95a90aacd52022-01-16WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist Rite AidSODIUM CHLORIDERITE AIDd583067e-1133-7d7d-e053-2a95a90a1e362022-01-13WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Sterile Saline MistSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC648da2bc-bc91-4295-9e46-d3055cdc24182022-01-08WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Nasal DripSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INCd5129a91-50e7-6b94-e053-2a95a90a2b302022-01-08WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Sterile Saline Mist Daily CareSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INCd5131ab2-8213-3659-e053-2a95a90ab2ab2022-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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