NDC 51688-6347 - 100/595/070 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: 51688-6347
Package NDCs from labels: 51688-6347-5
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	100/595/070 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	100/595/070 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	100/595/070 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	100/595/070 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	100/595/070 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	100/595/070 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	100/595/070 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	100/595/070 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	100/595/070 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	100/595/070 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	100/595/070 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	100/595/070 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	100/595/070 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	100/595/070 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 17 of 45 · 897 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
STERILE WATER	WATER	Henry Schein, Inc.	f4087143-9868-4308-b96c-43657ee8ec28	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Xylocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	6899113c-dee4-4227-9f68-475fcce6b91e	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: EC2CNF7XFP
Xylocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	cfcc8a07-b40c-476d-9a21-83487318ac85	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: EC2CNF7XFP
Xylocaine	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	ffc87dfb-0e26-4b42-80fd-3fb7690119e3	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: EC2CNF7XFP
Xylocaine	LIDOCAINE HCL	Henry Schein, Inc.	a6019956-a6e0-4988-a870-6aee06c354c3	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: EC2CNF7XFP
Bacteriostatic Water	BACTERIOSTATIC WATER	ProPharma Distribution	42c6938e-f747-ae13-e063-6294a90a59a3	2025-11-04	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Lidocaine Numbing Cream	LIDOCAINE 5%	YYBA Corp	1319ee69-8b3f-5815-e063-6294a90a5ad5	2025-11-03	Warnings	Exact identifier unii: EC2CNF7XFP
Sterile Water	WATER	ICU Medical Inc.	aab10f03-26ae-4dbc-a481-ef025e48b405	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	ICU Medical Inc.	e3484bc6-ed7f-43ef-9d49-c131a8dff2dd	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
EPINEPHRINE	EPINEPHRINE	Henry Schein, Inc.	3b1ac82f-6920-4e40-a77e-598398679f2d	2025-10-31	Warnings, Adverse reactions	Exact identifier unii: YKH834O4BH
epinephrine	EPINEPHRINE	Amneal Pharmaceuticals LLC	c0ef05d5-3fc8-4fb4-bf5b-c219ff17b092	2025-10-31	Warnings, Adverse reactions	Exact identifier unii: YKH834O4BH
Sterile Water	WATER	ICU Medical Inc.	1c0bbcb7-5ed6-4ee7-b297-080d3359474e	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Bacteriostatic Water	WATER	Henry Schein, Inc.	a833502e-a622-4e81-8c58-cef6ccb6c4c9	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Povidone Iodine Prep	POVIDONE IODINE	PHOENIX HEALTHCARE SOLUTIONS, LLC	c17603f2-3548-4225-b611-216c2763e51f	2025-10-23	Warnings	Exact identifier unii: 85H0HZU99M
Povidone Iodine Prep Swabstick	POVIDONE IODINE	PHOENIX HEALTHCARE SOLUTIONS, LLC	8a0aba34-3f96-46b6-8521-f4388fb73edf	2025-10-23	Warnings	Exact identifier unii: 85H0HZU99M
Povidone-Iodine Prep Pads Medium	POVIDONE-IODINE	Medline Industries, LP	28c05c5c-09d3-2c62-e054-00144ff8d46c	2025-10-23	Warnings	Exact identifier unii: 85H0HZU99M
Povidone-Iodine Swabsticks Singles	POVIDONE-IODINE	Medline Industries, LP	28c26a44-0699-4fa5-e054-00144ff88e88	2025-10-23	Warnings	Exact identifier unii: 85H0HZU99M
PROHEAL POVIDONE IODINE PREP PADS	POVIDONE-IODINE	Click Industries LLC	53733b6c-fa62-43e0-bfcc-3d23b5e1a95a	2025-10-23	Warnings	Exact identifier unii: 85H0HZU99M
POVIDONE-IODINE	POVIDONE-IODINE	James Alexander Corporation	181a6363-2249-45f0-a28b-79f2c5ffad59	2025-10-23	Warnings	Exact identifier unii: 85H0HZU99M
Povidone-Iodine	POVIDONE-IODINE	Medline Industries, LP	2b95078e-2caf-7005-e054-00144ff88e88	2025-10-22	Warnings	Exact identifier unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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