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
Label	Manufacturer	Effective date	Type
Lidocaine Hydrochloride and Epinephrine	Smiths Medical ASD, Inc. \| Hospira, Inc. \| Aplicare, Inc.	2013-01-17	MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EPINEPHRINE	ACTIVE INGREDIENT	YKH834O4BH	100/595/080 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 ANHYDROUS	ACTIVE INGREDIENT	EC2CNF7XFP	100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]	1
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]	1
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]	1
IODINE	ACTIVE MOIETY	9679TC07X4	100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	100/595/080 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 ACID	INACTIVE INGREDIENT	XF417D3PSL	100/595/080 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 MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]	1
NONOXYNOL-9	INACTIVE INGREDIENT	48Q180SH9T	100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	100/595/080 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, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	100/595/080 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA TRACHEOSTOMY TUBE AND INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	100/595/080 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 42 of 45 · 897 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adrenal Support	HUMULUS LUPULUS, ADRENALINUM, CORTISONE ACETICUM, SELENIUM METALLICUM, THYROIDINUM (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, FERRUM METALLICUM, NUX VOMICA, PHOSPHORUS, SEPIA, PHOSPHORICUM ACIDUM	Deseret Biologicals, Inc.	e7e01040-df38-4628-96d0-4df3420546a4	2022-11-09	Warnings	Exact identifier unii: YKH834O4BH
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION	Fenwal, Inc.	d55cb701-9664-4931-8754-1a8cae68da06	2022-11-01		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTION	Fenwal, Inc.	f9d7f1b4-7a77-44f9-8924-10b16008b49d	2022-11-01		Exact identifier unii: XF417D3PSL
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)	Fenwal, Inc.	4a08a9ec-46a5-4fcf-80ee-5c33f1a8b746	2022-11-01		Exact identifier unii: XF417D3PSL
Sterile Water	WATER	Fresenius Kabi USA, LLC	b45e9f1d-9c48-4b46-8541-d846b89540df	2022-10-26	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye wash	PURIFIED WATER	McKesson	bd089fde-24ba-4de5-e053-2995a90a39bb	2022-10-18	Warnings	Exact identifier unii: 059QF0KO0R
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	B. Braun Medical Inc.	e0e479e6-4c94-44d0-8074-d0ee7b2bde22	2022-10-13	Warnings, Adverse reactions	Exact identifier unii: EC2CNF7XFP
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	677c33a2-4e16-406e-e053-2991aa0a4594	2022-10-13	Warnings, Adverse reactions	Exact identifier unii: YKH834O4BH
Epinephrine	EPINEPHRINE	Asclemed USA, Inc.	099bc72c-8ffe-4b8c-9608-044c864982fb	2022-10-12	Warnings, Adverse reactions	Exact identifier unii: YKH834O4BH
Bach Original Flower Remedies Rock Water	WATER	Nelson Bach USA Limited	ea242559-1618-3354-e053-2a95a90a1a95	2022-10-03	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Medical Purchasing Solutions, LLC	e90b47e3-9636-b9ee-e053-2a95a90ad48c	2022-09-19	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Betadine	POVIDONE-IODINE	Alcon Laboratories, Inc.	b026de1b-9949-4557-ac49-c7b0038c24cd	2022-06-29	Warnings, Adverse reactions	Exact identifier unii: 85H0HZU99M
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Adrenal Support	ARALIA QUINQUEFOLIA, HUMULUS LUPULUS, ADRENALINUM, CORTISONE ACETICUM, SELENIUM METALLICUM, THYROIDINUM (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, FERRUM METALLICUM, NUX VOMICA, PHOSPHORUS, SEPIA, PHOSPHORICUM ACIDUM	Deseret Biologicals, Inc.	37a7f63c-4241-492b-af7c-7e5bbe0a0889	2022-06-21	Warnings	Exact identifier unii: YKH834O4BH
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Stomach Saver	ABIES NIG, ANTIMON CRUD, ARG NIT, ARSENICUM ALB, CARBO VEG, CINCHONA, LYCOPODIUM, NAT PHOS, NUX MOSCH, NUX VOM, PODOPH PELT, ROBINIA	Silver Star Brands	e0048c51-74e3-a7ff-e053-2995a90a1d41	2022-05-27	Warnings	Exact identifier unii: GR686LBA74
ACD Blood-Pack Units (PL 146 PLASTIC)	ANTICOAGULANT CITRATE DEXTROSE (ACD)	Fenwal, Inc.	ba894daa-688e-4a9e-bd74-e71797f951bb	2022-04-27		Exact identifier unii: XF417D3PSL
Povidone-Iodine Pad	POVIDONE-IODINE	Shandong Haiyan Medical Manufacture Co., Ltd.	c9187a07-92d5-15ac-e053-2995a90af4cb	2022-03-19	Warnings	Exact identifier unii: 85H0HZU99M
STRESS / FATIGUE	EPINEPHRINE, THYROID UNSPECIFIED,BOS TAURUS PITUITARY GLAND, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE CRUDE, CONIUM MACULATUM FLOWERING TOP, CORTISONE ACETATE, CROTALUS HORRIDUS HORRIDUS VENOM, IRON, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, SELENIUM, SEPIA OFFICINALIS JUICE, ZANTHOXYLUM AMERICANUM BARK	Natural Creations, Inc.	4c28ec7f-4490-4106-8472-d94c7073c306	2022-03-03	Warnings	Exact identifier unii: YKH834O4BH
ACD-A	ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A	Fenwal, Inc.	22805f0d-ba58-41ea-b245-19980abcda22	2022-02-11		Exact identifier unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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