FDA.reportPublic FDA data

NDC 51688-6258 - 100/596/080 ULTRAperc Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator with Blue Line Ultra Suctionaid Tracheostomy Tube with Introducer

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
51688-6258
Package NDCs from labels
51688-6258-5
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2013-01-18
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.2013-01-18MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE MOIETYYKH834O4BH100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X4100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0R100/596/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () 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 30 of 45 · 888 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Maokang Medical 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd644e92c3-3043-4a76-9845-7e0482cf9f622024-07-19WarningsExact identifier
unii: 85H0HZU99M
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAmerican Health Packaging58fa9952-c8ab-4ebb-a073-15cc45f4832a2024-07-16Adverse reactionsExact identifier
unii: XF417D3PSL
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
MedlinePOVIDONE-IODINEMedline Industries, LP11fd1661-1b8c-b65b-e063-6394a90af89b2024-07-01WarningsExact identifier
unii: 85H0HZU99M
Maokang Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdb3b885b6-5278-491f-ae75-8b7032fcccd82024-06-26WarningsExact identifier
unii: 85H0HZU99M
EpinephrineEPINEPHRINEInternational Medication Systems, Limited7b6ffd77-8b25-4ff1-993e-dbfd7e0834cf2024-06-19Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
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
XYLOCAINEXYLOCAINEHF Acquisition Co LLC, DBA HealthFirst17e77013-f2a0-b1f7-e063-6294a90ae4682024-05-29Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
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
XYLOCAINE MPFXYLOCAINE MPFHF Acquisition Co LLC, DBA HealthFirst18705416-9593-43f2-e063-6294a90a31b42024-05-14Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
Weight Loss Support Plus Female BalanceFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM (NSPC), PHYTOLACCA DECANDRA, RUBUS IDAEUS, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUS, HEPAR SULPHURIS CALCAREUM, OXYTOCIN, PROGESTERONECarolinas Weight Loss Institute52ce70ad-7ed6-4559-8c4c-590bf7b10e652024-05-13WarningsExact identifier
unii: YKH834O4BH
Xylocaine MPFLIDOCAINE HYDROCHLORIDEFresenius Kabi USA, LLCd5e0d06f-ba1e-44d4-aa89-39d6c146dc232024-05-13Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
Weight Loss Support Plus ThyroidFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN, RUTINIC ACID, IODIUM, CAPSICUM ANNUUM, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM, PHYTOLACCA DECANDRA, SPONGIA TOSTA, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUS, LAPIS ALBUSCarolinas Weight Loss Institutebb712c7e-d97e-4b7f-92f9-1726cdc4a4342024-05-09WarningsExact identifier
unii: YKH834O4BH
Weight Loss Support Plus Immune SupportFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), PETROSELINUM SATIVUM, CAPSICUM ANNUUM, GALIUM APARINE, HYDRASTIS CANADENSIS, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM (NSPC), PHYTOLACCA DECANDRA, THYROIDINUM (BOVINE), THYMUS (BOVINE THYMUS GLAND), PITUITARUM POSTERIUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUSCarolinas Weight Loss Institute02fbc0ad-067a-45b3-99d0-6f2301ff91132024-05-09WarningsExact identifier
unii: YKH834O4BH
BP RegADRENALINUM, ALLIUM SATIVUM, ALPHA-LIPOICUM ACIDUM, ARTERIA SUIS, AURUM METALLICUM, CACTUS GRANDIFLORUS, CHOLESTERINUM, CORTISONE ACETICUM, COUMARINUM, FORMALINUM, GLONOINUM, KALI CHLORICUM, LACHESIS MUTUS, PROTEUS (VULGARIS), RAUWOLFIA SERPENTINA, STRONTIUM CARBONICUM, SULPHUR, THYROIDINUM (SUIS), VENA SUIS, VERATRUM ALBUMDeseret Biologicals, Inc.540c1149-b6d4-4926-87e8-73a920f87b4a2024-05-09WarningsExact identifier
unii: YKH834O4BH

Reported adverse events (FAERS/openFDA)#

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