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 35 of 45 · 897 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Povidone Iodine	POVIDONE-IODINE SPRAY 5%	Humco Holding Group, Inc.	a7bb80c4-bbc0-21ea-e053-2995a90a52c1	2023-12-15	Warnings	Exact identifier unii: 85H0HZU99M
Povidone Iodine	POVIDONE IODINE 10%	Humco Holding Group, Inc.	6064c23b-7c15-208d-e053-2991aa0a00f6	2023-12-15	Warnings	Exact identifier unii: 85H0HZU99M
Povidone Iodine	POVIDONE IODINE GARGLE 0.5%	Humco Holding Group, Inc.	a7b9ad55-cfeb-6066-e053-2a95a90af975	2023-12-15	Warnings	Exact identifier unii: 85H0HZU99M
Povidone Iodine	POVIDONE IODINE ORAL RINSE 0.5%	Humco Holding Group, Inc.	b83dbdd1-ff63-caf8-e053-2a95a90a5764	2023-12-15	Warnings	Exact identifier unii: 85H0HZU99M
Rite Aid Povidone Iodine	POVIDONE IODINE 10%	Rite Aid Corporation	5df6ff37-a4ea-d666-e053-2991aa0a9786	2023-12-15	Warnings	Exact identifier unii: 85H0HZU99M
Povidone-Iodine Prep Sterile	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	bb62784a-d7b7-471e-9aed-0c6d2e349c3a	2023-12-13	Warnings	Exact identifier unii: 85H0HZU99M
Oracit	CITRIC ACID AND SODIUM CITRATE	CMP Pharma, Inc.	bc26abed-8e6e-475d-8ab3-abf7d0377003	2023-12-07	Adverse reactions	Exact identifier unii: 2968PHW8QP
Eye Wash	WATER	Jiangxi Zhenmei Biological Technology Co.,Ltd	c68795b8-bf68-0d01-e053-2a95a90abebb	2023-12-04	Warnings	Exact identifier unii: 059QF0KO0R
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	A-S Medication Solutions	38610ee9-4e70-4a8a-a5c5-6c148cf145f0	2023-12-04	Warnings, Adverse reactions	Exact identifier unii: EC2CNF7XFP
Epinephrine	EPINEPHRINE	A-S Medication Solutions	b7a4171c-7934-4723-a140-bd93ea84aae1	2023-11-21	Warnings, Adverse reactions	Exact identifier unii: YKH834O4BH
Phexxi	LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE	Evofem, Inc.	173ff411-7227-47b0-94dc-844e1ebaf14e	2023-11-21	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
Prep non sterile	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	ecbe037b-77da-4ffc-8c60-e56f428766af	2023-11-15	Warnings	Exact identifier unii: 85H0HZU99M
Prep Pad Sterile	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	758abf53-ad8a-62ac-e053-2991aa0a8f0c	2023-11-15	Warnings	Exact identifier unii: 85H0HZU99M
Muriaticum acidum	HYDROCHLORIC ACID	Boiron	8643994f-4e13-4572-e053-2991aa0a5b78	2023-11-14		Exact identifier unii: QTT17582CB
Muriaticum acidum	HYDROCHLORIC ACID	Boiron	6907bbfe-caa5-2ce4-e053-2991aa0ade8d	2023-11-14		Exact identifier unii: QTT17582CB
Muriaticum acidum	HYDROCHLORIC ACID	Boiron	8643c518-13b2-658a-e053-2a91aa0ac5ed	2023-11-14		Exact identifier unii: QTT17582CB
Muriaticum acidum	HYDROCHLORIC ACID	Boiron	8643e30e-1f47-09f1-e053-2991aa0ac2de	2023-11-14		Exact identifier unii: QTT17582CB
Maokang Povidone Iodine Swabsticks 3s	POVIDONE-IODINE	Changzhou Maokang Medical Products Co.,Ltd	15443c2d-b531-4635-8d0c-53057bee0db7	2023-11-14	Warnings	Exact identifier unii: 85H0HZU99M
TWO PVP-I SCRUB STICKS	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	88bee1c7-0d6d-46b7-8dce-ce05aa0388fa	2023-11-10	Warnings	Exact identifier unii: 85H0HZU99M
TWO PVP-I SCRUB LARGE WINGED SPONGES	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	4295c0c5-6be0-4d0f-9456-a92e3571d679	2023-11-10	Warnings	Exact identifier unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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