FDA.reportPublic FDA data

NDC 51688-6346 - 100/573/000 ULTRAperc Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for 7, 8 and 9mm Tubes Only. Without Tracheostomy Tube.

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
51688-6346
Package NDCs from labels
51688-6346-5
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2013-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lidocaine Hydrochloride and EpinephrineSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.2013-01-23MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
EPINEPHRINEACTIVE MOIETYYKH834O4BH100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
IODINEACTIVE MOIETY9679TC07X4100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
LIDOCAINEACTIVE MOIETY98PI200987100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0R100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [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 1 of 46 · 915 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Henry Schein Povidone-Iodine Prep PadPOVIDONE-IODINEHenry Schein, Inc.313416b8-60b2-4a77-9b56-5c507aae90722026-09-08WarningsExact identifier
unii: 85H0HZU99M
Tree PollenACER NEGUNDO, ACER RUBRUM, ADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, BETULA NIGRA, EUPHRASIA OFFICINALIS, FRAXINUS AMERICANA, HISTAMINUM HYDROCHLORICUM, LIGUSTRUM VULGARE, LIQUIDAMBAR STYRACIFLUA, MORUS ALBA, PINUS STROBUS, POPULUS DELTOIDES, QUERCUS RUBRA, SABADILLA, SALIX NIGRA, SANGUINARIA CANADENSISNaturalCarefeea837e-7ce3-4575-8cb8-451f5385cf972026-09-03WarningsExact identifier
unii: YKH834O4BH
EPINEPHRINEEPINEPHRINEREMEDYREPACK INC.55befbe4-c819-4367-bbe7-de5841786aac2026-09-03Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Aplicare Povidone-IodinePOVIDONE-IODINEAplicare Products, LLC7302a2f8-a600-4200-bc4e-309e4c190fe52026-09-02WarningsExact identifier
unii: 85H0HZU99M
Aplicare Povidone-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCb8a23a29-2541-4987-a534-17a6369a6c8d2026-09-02WarningsExact identifier
unii: 85H0HZU99M
XYLOCAINE MPFLIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst1986c302-82a0-95a9-e063-6294a90a33392026-09-02Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: YKH834O4BH
EPINEPHRINEEPINEPHRINEREMEDYREPACK INC.5ba14408-c8fb-4734-aad9-ee19696acac22026-08-28Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Povidone-Iodine Topical AntisepticPOVIDONE-IODINEMedline Industries, LPc9036a83-22f5-4a09-b01c-7093d4192c192026-08-28WarningsExact identifier
unii: 85H0HZU99M
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: YKH834O4BH
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEREMEDYREPACK INC.1414bcfc-1543-4ad4-83bd-4fc444a02e922026-08-27Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Povidone Iodine SwabstickPOVIDONE IODINE 10%Trifecta Pharmaceuticals USA LLC59f82f9d-8c39-6890-e063-6294a90a090e2026-08-26WarningsExact identifier
unii: 85H0HZU99M
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AIBRAVEGYNECOLOGICAL INTIMATE CARE GELTupelo Brittany LLC59b64d3e-4673-a747-e063-6294a90aece92026-08-23WarningsExact identifier
unii: 85H0HZU99M
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Povidone-IodinePOVIDONE-IODINEMajor Pharmaceuticals59041ca3-a195-5a20-e063-6394a90a2ac92026-08-14WarningsExact identifier
unii: 85H0HZU99M
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: XF417D3PSL
Adrenal-ToneADRENALINUM, AVENA, GINKGO, GLYCYRRHIZA, KALI PHOS, NAT MUR, NUX VOMICA, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SARSAPARILLA, THYROIDINUM, VERATRUM ALB, ZINC MET.Energetix Corporation1ea4abb3-3a02-4d5c-baeb-d903b0febbb52026-08-11WarningsExact identifier
unii: YKH834O4BH
Aller-Chord AALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, BRYONIA (ALBA), CITRICUM ACIDUM, COUMARINUM, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, JUNIPERUS COMMUNIS, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, PHOSPHORUS, POTHOS FOETIDUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUR, TANACETUM VULGARE, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSEEnergetix Corporation09e89c92-112d-4320-9df5-b9f938bb90952026-08-11WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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