FDA.reportPublic FDA data

NDC 51688-9447 - 49661-25 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
51688-9447
Package NDCs from labels
51688-9447-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2016-09-28
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.2016-09-28MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT849661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH49661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP49661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M49661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
BUPIVACAINEACTIVE MOIETYY8335394RO49661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE MOIETYYKH834O4BH49661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X449661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
LidocaineACTIVE MOIETY98PI20098749661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OK49661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP49661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB49661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T49661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X49661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I49661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C49661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA7449661-25 SPINAL 25G WHITACRE () C47916 [SMITHS MEDICAL ASD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0R49661-25 SPINAL 25G WHITACRE () C47916 [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 78 of 113 · 2,258 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lung LiquescenceEUCALYPTUS GLOBULUS, LUNG (BOVINE), SANGUINARIA CANADENSIS, ADRENALINUM, BELLADONNANutritional Specialties, Inc.90fa56f2-23ba-412b-884c-d0e44f9bf8a02024-08-05WarningsExact identifier
unii: YKH834O4BH
Lidotral 5 Percent Roll On GelLIDOCAINE HYDROCHLORIDEPuretek Corporation1c4c9ce5-f12d-9c47-e063-6294a90a0b3c2024-08-02Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
epinephrineEPINEPHRINEAsclemed USA, Inc.0a29fe62-e241-4272-b91c-c1036b031cd42024-08-02Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Lymph/Spleen ComboADENOSINUM TRIPHOSPHORICUM DINATRUM, APIS MELLIFICA, CASTANEA VESCA, CEANOTHUS AMERICANUS, CHININUM ARSENICOSUM, FERRUM METALLICUM, HELIANTHUS ANNUUS, JUNIPERUS COMMUNIS, LYMPH NODE (SUIS), MYOSOTIS ARVENSIS, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, QUERCUS GLANDIUM SPIRITUS, SPLEEN (SUIS), SUCCINUM, THYMUS (SUIS), UBIDECARENONUMDeseret Biologicals, Inc.afce86e2-cbfa-44d4-b803-bc2ad50533572024-07-31WarningsExact identifier
unii: 451W47IQ8X
Lymph/Spleen ComboJUNIPERUS COMMUNIS, QUERCUS GLANDIUM SPIRITUS, MYOSOTIS ARVENSIS, NATRUM SULPHURICUM, CEANOTHUS AMERICANUS, HELIANTHUS ANNUUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CHININUM ARSENICOSUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, FERRUM METALLICUM, SUCCINUM, CASTANEA VESCA, APIS MELLIFICADeseret Biologicals, Inc.b55787b5-5e35-4342-8f00-ef202c3538772024-07-31WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: 451W47IQ8X
Adrenal SupportARALIA QUINQUEFOLIA, HUMULUS LUPULUS, ADRENALINUM, CORTISONE ACETICUM, SELENIUM METALLICUM, THYROIDINUM (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, FERRUM METALLICUM, NUX VOMICA, PHOSPHORUS, SEPIA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.50f48780-b222-471a-afa5-1504960d48942024-07-29WarningsExact identifier
unii: YKH834O4BH
Lidotral 5% GelLIDOCAINE HCLPuretek Corporation1e183af7-73d7-ff32-e063-6294a90a305b2024-07-25Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst96117178-ebf0-1335-e053-2a95a90ac1052024-07-24Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
CirculationNIACIN, NICOTINAMIDUM, ARNICA MONTANA, CAMPHORA, NUX VOMICA, VERATRUM ALBUM, ADRENALINUM, AESCULUS HIPPOCASTANUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HELODERMA (HORRIDUS), RHUS TOX, TABACUMNutritional Specialties, Inc.f8b51780-1644-477a-a3e4-5798c28bedfc2024-07-24WarningsExact identifier
unii: YKH834O4BH
AssistFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM (NSPC), PHYTOLACCA DECANDRA, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUSNutritional Specialties, Inc.0d2f4af6-950b-4c37-8dab-55ea9f87e3cd2024-07-24WarningsExact identifier
unii: YKH834O4BH
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationf55bd888-5e01-474d-871b-24654c0701782024-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC83994d0c-8484-4505-abb5-8a384ed122882024-07-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Maokang Medical 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd644e92c3-3043-4a76-9845-7e0482cf9f622024-07-19WarningsExact identifier
unii: 85H0HZU99M
CVS Health Sunburn Relief CoolingLIDOCAINE HYDROCHLORIDECVS PHARMACY1d6402ea-4201-27f9-e063-6294a90a43f52024-07-16WarningsExact identifier
unii: V13007Z41A
sodium chlorideSODIUM CHLORIDEBecton Dickinson and Company8df7dcf6-8714-6caf-e053-2995a90ab8cc2024-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Burn ReliefLIDOCAINE HCI 2.0%Trifecta Pharmaceuticals USA, LLC.e5e524cd-bb22-715f-e053-2995a90ab5d32024-07-12WarningsExact identifier
unii: V13007Z41A
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDENorthStar RxLLCf065e6d2-b47e-433d-a1fb-f0449cd725f12024-07-05Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
MedlinePOVIDONE-IODINEMedline Industries, LP11fd1661-1b8c-b65b-e063-6394a90af89b2024-07-01WarningsExact identifier
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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