FDA.reportPublic FDA data

NDC 51688-6348 - 100/595/080 Ultraperc Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator with Blue Line Ultra 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
51688-6348
Package NDCs from labels
51688-6348-5
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2013-01-17
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.2013-01-17MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE MOIETYYKH834O4BH100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X4100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0R100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA 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 11 of 46 · 902 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betadine GarglePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.5f0a3377-1398-2603-c632-f0d214bb88ec2026-01-21WarningsExact identifier
unii: 85H0HZU99M
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1b1e224c-8c00-46ea-9bdd-020a9b45321d2026-01-21WarningsExact identifier
unii: 85H0HZU99M
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Maokang Povidone-Iodine ScrubPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd5f945e64-aee7-4b68-ad8b-9c8d4875842a2026-01-20WarningsExact identifier
unii: 85H0HZU99M
Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATEProPharma Distribution48c0ee87-f722-1a71-e063-6394a90a72d12026-01-19Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATEB. Braun Medical Inc.7dff29d9-522d-40eb-a9d9-42377912d6402026-01-14Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
EPINEPHRINEEPINEPHRINEHenry Schein, Inc.af10f2bb-b0ad-45a6-b525-e715613350af2026-01-13Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Povidone IodinePOVIDONE-IODINESion Biotext Medical Ltd04438f9e-302c-431b-b3ad-d2c50ca01ad82026-01-12WarningsExact identifier
unii: 85H0HZU99M
Epinephrine PediatricsEPINEPHRINE 0.15 PEDIATRICSSina Health Inc287930f8-c5c6-56bd-e063-6394a90ad32e2026-01-12Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Adrenalin VialsEPINEPHRINESina Health Inc28649937-8ae1-a022-e063-6394a90aebe02026-01-12Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Epinephrine 0.3 AdultsEPINEPHRINE 0.3 ADULTSSina Health Inc28642ad9-b839-ce3a-e063-6394a90ab8662026-01-12Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Epinephrine 0.3 AdultsEPINEPHRINE 0.3 ADULTSSina Health Inc2865e9a5-1228-e2bc-e063-6394a90af94e2026-01-12Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Epinephrine 0.15 PediatricsEPINEPHRINE 0.15 PEDIATRICSSina Health Inc28649bcc-648c-c977-e063-6394a90a0b2b2026-01-12Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Povidone Iodine Prep PadPOVIDONE-IODINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.6d472aef-0d95-4c21-a373-bd16bc7b63ed2026-01-12WarningsExact identifier
unii: 85H0HZU99M
Sunmark Saline Single LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMStrategic Sourcing Services LLC06720229-7d58-499e-b7de-cb4bda5ae4162026-01-08WarningsExact identifier
unii: GR686LBA74
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Adrenal Liquescence 3001ADRENAL LIQUESCENCEProfessional Complementary Health Formulas0388d3c7-4b3b-4e74-8c1b-9a2af2a4377d2026-01-08WarningsExact identifier
unii: YKH834O4BH
Epinephrine 1553EPINEPHRINEProfessional Complementary Health Formulasc06d262b-b97e-4921-b927-c51e1b27691e2026-01-08WarningsExact identifier
unii: YKH834O4BH

Reported adverse events (FAERS/openFDA)#

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