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 45 of 45 · 897 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	794f724c-87f0-49c1-9b26-c9e491978313	2019-11-18		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	5c7d3287-883a-459b-9214-074a583c8a59	2019-11-18		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	448a1dc5-7a98-4b2f-82af-4b92de05cfc3	2019-11-18		Exact identifier unii: XF417D3PSL
FREDS SALINE TWIN PACK LAXATIVE	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	FRED'S	7d15057f-eb3b-477f-ab14-68c3c38ea910	2018-12-26	Warnings	Exact identifier unii: GR686LBA74
Imucode	ASTRAGALUS, HYDRASTIS, ADRENALINUM, THYROIDINUM, PITUITARUM POSTERIUM, ARSENICUM ALB, BAPTISIA, BARYTA CARB, BARYTA MUR, BROMIUM, CANDIDA ALB, CEANOTHUS, CHININUM SULPH, CONIUM, HEPAR SULPH CALC, IGNATIA, INDIUM, IODIUM, MERC SOLUB, PHYTOLACCA, SULPHUR	Natural Creations, Inc	be30901c-0673-4af0-8128-83ed59ff04b1	2018-12-21	Warnings	Exact identifier unii: YKH834O4BH
GUNA-ALLERGY-PREV	AMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -	Guna spa	adae93c0-1de9-4e45-ab58-148171f0dc86	2018-12-21	Warnings	Exact identifier unii: 2968PHW8QP
GUNA-DIZZY	.ALPHA.-KETOGLUTARIC ACID - AMBERGRIS - ANAMIRTA COCCULUS SEED - CONIUM MACULATUM FLOWERING TOP - EPINEPHRINE - FUMARIC ACID - MALIC ACID - MELATONIN - MINERAL OIL - PTERIDIUM AQUILINUM ROOT - PYRIDOXINE HYDROCHLORIDE - QUINHYDRONE - QUININE - SUS SCROFA ARTERY - SUS SCROFA CEREBELLUM - SUS SCROFA PLACENTA - THIAMINE HYDROCHLORIDE - TOBACCO LEAF -	Guna spa	c5f4a798-e628-4388-a98d-7449dd92f2d6	2018-12-21	Warnings	Exact identifier unii: YKH834O4BH
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R
Bio Rock Water	ROCK WATER	BioActive Nutritional, Inc.	178bd16d-0d4f-49d8-866b-8ab3a3c6889d	2018-07-30	Warnings	Exact identifier unii: 059QF0KO0R
Marcs Twin Pack	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Marc Glassman Inc.	66348ee5-803a-4b78-94dd-55bc9d3543c3	2018-07-10	Warnings	Exact identifier unii: GR686LBA74
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
QUALITY CHOICE SINGLE SALINE LAXATIVE	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Alcyon Health, LLC.	eb499c7f-9c7b-4097-83a3-82aabffd6beb	2017-07-12	Warnings	Exact identifier unii: GR686LBA74
Pro-Enema Single Saline Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Propharma Medical Supplies	e53c5eda-21da-4aed-a592-315100167cc2	2017-06-08	Warnings	Exact identifier unii: GR686LBA74
Saline Laxative Cherry Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Dolgencorp Inc.	ca3c00d9-4301-4de8-94f5-34f1bcc761ab	2017-04-13	Warnings	Exact identifier unii: GR686LBA74
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	051f7347-5a76-4664-8fe2-e61b3dfcb0e4	2014-08-27		Exact identifier unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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