FDA.reportPublic FDA data

NDC 51688-9650 - 15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY

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
51688-9650
Package NDCs from labels
51688-9650-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | Aplicare, Inc.
Effective date
2012-07-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHYSmiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | Aplicare, Inc.2012-07-25MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT815919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
BUPIVACAINEACTIVE MOIETYY8335394RO15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X415919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
LidocaineACTIVE MOIETY98PI20098715919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH3715919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA7415919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0R15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1

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 48 of 71 · 1,420 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst950d82b6-76a1-0c08-e053-2a95a90a3a922024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Bupivacaine hydrochlorideBUPIVACAINE HYDROCHLORIDESomerset Therapeutics, LLCbcaab86f-20f0-4482-8d73-e29b36dced582024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Derma Pain PlusCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)Peaceful Mountain, Inc.6fa79c31-e48e-4c83-baa2-96cef22cfee12024-06-13WarningsExact identifier
unii: 451W47IQ8X
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: 451W47IQ8X
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
NATRUM MURNATRUM MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a22655a-68f3-4f13-e063-6294a90ae52c2024-06-05WarningsExact identifier
unii: 451W47IQ8X
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
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
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
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC239a5af1-7498-480f-862c-ab7c3d89d1832024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
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
XYLOCAINE MPFXYLOCAINE MPFHF Acquisition Co LLC, DBA HealthFirst18705416-9593-43f2-e063-6294a90a31b42024-05-14Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.4510fe59-cc28-4585-925f-42508a60abd02024-05-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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