FDA.reportPublic FDA data

NDC 51688-6352 - 100/596/070 ULTRAperc Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator with Blue Line Ultra Suctionaid Tracheostomy Tube and 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
51688-6352
Package NDCs from labels
51688-6352-5
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 INGREDIENTYKH834O4BH100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE MOIETYYKH834O4BH100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X4100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0R100/596/070 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE AND 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 19 of 45 · 897 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.121eb51a-befe-47ea-85c6-d77e8c7e58642025-10-06WarningsExact identifier
unii: XF417D3PSL
Pollen and Dander LiquescenceALLIUM CEPA, EUPHRASIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), SABADILLA, AMBROSIA ARTEMISIAEFOLIA, APIS MELLIFICA, GALIUM APARINE, GLANDULA SUPRARENALIS (BOVINE), HEPAR SUIS, HYDRASTIS CANADENSIS, ADRENALINUM, EPHEDRA VULGARIS, HISTAMINUM HYDROCHLORICUMNutritional Specialties, Inc.395b8a0e-b718-4d6f-9b24-b80119b903482025-10-06WarningsExact identifier
unii: YKH834O4BH
Profend Nasal DecolonizationPOVIDONE IODINE USP, 10% W/WProfessional Disposables International, Inc.6245b1e5-6637-18bc-e053-2a91aa0aa9812025-10-02WarningsExact identifier
unii: 85H0HZU99M
Auvi-QEPINEPHRINEkaleo, Inc6180fb40-7fca-4602-b3da-ce62b8cd24702025-10-02Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Leader Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMCardinal Health1b4f9c28-0547-4922-aa15-990c6fd9dc9f2025-09-29WarningsExact identifier
unii: GR686LBA74
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Care27c29a33-d1cc-d72f-e063-6394a90a4d452025-09-19WarningsExact identifier
unii: 85H0HZU99M
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Caref5252b4f-5e14-509e-e053-2995a90a6db82025-09-18WarningsExact identifier
unii: 85H0HZU99M
Saline LaxativeSALINE LAXATIVEMajor Pharmaceuticalsb3758ffe-1bac-4df6-9714-5e33e9d28d902025-09-16WarningsExact identifier
unii: GR686LBA74
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First PVP Iodine WipesPOVIDONE IODINE 10%Unifirst-First Aid406b4a37-816a-5ea4-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 85H0HZU99M
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
epinephrineEPINEPHRINEASCLEMED USA INC.76f65a94-4b26-4c40-8a74-79a73afbb4e22025-09-04Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Povidone Iodine PrepPOVIDONE IODINESion Biotext Medical Ltde05af551-647d-4278-bb7f-86f888ddbb8b2025-09-04WarningsExact identifier
unii: 85H0HZU99M
Aplicare Povidone-IodinePOVIDONE-IODINEAplicare Products, LLC91aef86d-ce8b-45be-bce9-74450292e0cd2025-09-02WarningsExact identifier
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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