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 43 of 45 · 890 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.d763511e-f1a7-4014-94b9-f7ad8f023ff42021-12-02Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.cf9f43a0-c750-4cf0-ac49-176ab2105aab2021-12-02Exact identifier
unii: XF417D3PSL
InterSolPLATELET ADDITIVE 3Fenwal, Inc.e4f06c0b-7cb1-49c9-97a4-2cfc212984952021-11-16Warnings, Adverse reactionsExact identifier
unii: GR686LBA74
Solucion InterSolSOLUCION ADITIVA PARA PLAQUETAS 3Fenwal, Inc.d5eaf5f4-67d3-4475-af9a-f5b0f882f5d12021-10-04Warnings, Adverse reactionsExact identifier
unii: GR686LBA74
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCba082c2f-64f4-419d-9c88-74f203316e172021-08-25Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FungisodeARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHURSeroyal USA55c5dfc4-3757-6ac2-e054-00144ff88e882021-07-22WarningsExact identifier
unii: QTT17582CB
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Candid- YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c68c9c20-3a07-16df-e053-2a95a90a0cbc2021-02-01WarningsExact identifier
unii: YKH834O4BH
Candid-YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c68ea9c3-f95c-dbcd-e053-2995a90a9aeb2021-02-01WarningsExact identifier
unii: YKH834O4BH
Candid-YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c6a37dbe-3092-5ecf-e053-2a95a90a7c392021-02-01WarningsExact identifier
unii: YKH834O4BH
EpinephrineEPINEPHRINETeva Pharmaceuticals USA, Inc.04f07f15-55e2-411b-abb8-07eab37f56642021-01-31Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
TOTAL PRO-JESADRENAL,BELLADONNA,CHELIDONIUM,DIOSCOREAVILLOSA,FOLLICULINUM,HYPOTHALAMUS,ARGININE,LILIUMTIGRINIUM,LIVER,OOPHORINUM,PINEAL,PITUITARINUM,PLACENTANIUM,PROGESTERONEWhite Manufacturing Inc. BDA Micro-Westb26953f8-7b56-432c-958c-d80c528fbb6a2021-01-21WarningsExact identifier
unii: YKH834O4BH
TOTAL FEM BALADRENALINUM, CHOLESTERINUM, FOLLICULINUM, HYPOTHALAMUS, OOPHORINUM, PULSATILLAWhite Manufacturing Inc. DBA Micro-West0f61111c-5472-45bf-8ce7-a7c4d12fc21b2021-01-21WarningsExact identifier
unii: YKH834O4BH
TOTAL TRI-ESTROADRENALINUM, CIMICIFUGA, IGNATIA, LECITHIN, NICOTINAMIDUM, OOPHORINUM, SEPIA.White Manufacturing Inc. DBA Micro-Westd3a5e7b6-a4d2-406e-b837-600a886b0ff42021-01-21WarningsExact identifier
unii: YKH834O4BH
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Pollen-WeedsGINKGO BILOBA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ADRENALINUM , ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, ARTEMISIA VULGARIS, BAPTISIA TINCTORIA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, DIOSCOREA VILOSA, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, KALI IODATUM, LACHESIS MUTUS, LILIUM TIGRINUM,Newton Laboratories, Inc.99e92cc0-2c25-d814-e053-2a95a90aa2582020-12-07WarningsExact identifier
unii: YKH834O4BH
ExhaustionACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA.Newton Laboratories, Inc.98fc56b6-afed-2cfd-e053-2995a90a59ae2020-12-03WarningsExact identifier
unii: YKH834O4BH
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b59731a2-c775-7e8a-e053-2a95a90a90622020-12-03WarningsExact identifier
unii: YKH834O4BH

Reported adverse events (FAERS/openFDA)#

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