FDA.reportPublic FDA data

NDC 51688-9571 - 15597-20 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
51688-9571
Package NDCs from labels
51688-9571-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2013-03-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Epinephrine - Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.2013-03-11MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT815597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083G15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41A15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OK15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
BUPIVACAINEACTIVE MOIETYY8335394RO15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
EPINEPHRINEACTIVE MOIETYYKH834O4BH15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
IODINEACTIVE MOIETY9679TC07X415597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
LIDOCAINEACTIVE MOIETY98PI20098715597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OK15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C15597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA7415597-20 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0R15597-20 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 80 of 116 · 2,307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidotral Five PercentLIDOCAINE HYDROCHLORIDEPureTek Corporation1a156ffe-1ec9-d2f9-e063-6394a90a33812024-06-04Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDEEpic Medical Supply Corpbd1b1873-e900-45eb-96a0-28f782b5a7cd2024-06-04WarningsExact identifier
unii: V13007Z41A
Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent CreamLIDOCAINE HCL, HYDROCORTISONE ACETATEPureTek Corporation1a01b416-2ca5-c7fa-e063-6394a90a341b2024-06-03Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 2968PHW8QP
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEA-S Medication Solutions1091d4d8-5dad-46e1-8f26-7bc0c5dd833f2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
XYLOCAINEXYLOCAINEHF Acquisition Co LLC, DBA HealthFirst17e77013-f2a0-b1f7-e063-6294a90ae4682024-05-29Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
Mentox HPAURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.ebb23637-4931-4563-ab30-99bea02765802024-05-28WarningsExact identifier
unii: 451W47IQ8X
THE SOLUTION NUMBINGLIDOCAINE HYDROCHLORIDESCALP TECH INC184be4cc-b0b9-7882-e063-6394a90a8e7e2024-05-25WarningsExact identifier
unii: V13007Z41A
Weight Loss Support Plus Female BalanceFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, CAULOPHYLLUM THALICTRINES, CIMICIFUGA RACEMOSA, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM, PHYTOLACCA DECANDRA, RUBUS IDAEUS, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUS, HEPAR SULPHURIS CALCAREUM, PROGESTERONE, OXYTOCINCarolinas Weight Loss Institute66249339-1e80-449f-9c2a-a030cdc71a0c2024-05-23WarningsExact identifier
unii: YKH834O4BH
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLCdbed53b7-0109-4561-8342-0178ec8c64b02024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: LX22YL083G
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: LX22YL083G
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC239a5af1-7498-480f-862c-ab7c3d89d1832024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TheraCare 4% Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcarec808aa05-9d49-cc9f-e053-2a95a90a50f32024-05-21WarningsExact identifier
unii: V13007Z41A
Sodium chlorideSODIUM CHLORIDEBecton Dickinson and Companyebc8b008-a8b3-4c41-89e4-b413f7aab89f2024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: 451W47IQ8X
ColoparCOLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALISEnergique, Inc.c47d7203-abcd-4ae5-bf9b-5df07e07d3c12024-05-20WarningsExact identifier
unii: 451W47IQ8X
SAFLY BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.3aca2568-d10f-4b14-861b-6c741c1068292024-05-17WarningsExact identifier
unii: V13007Z41A
Lidotral Two PercentLIDOCAINE HYDROCHLORIDEPureTek Corporation185d3e09-4005-b032-e063-6294a90a5efe2024-05-14Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
XYLOCAINE MPFXYLOCAINE MPFHF Acquisition Co LLC, DBA HealthFirst18705416-9593-43f2-e063-6294a90a31b42024-05-14Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP

Reported adverse events (FAERS/openFDA)#

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