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 43 of 45 · 897 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
BHI Hemorrhoid	HORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFUR	MediNatura Inc	d7df7d3e-48ad-4f58-aef5-a7bd48d2f191	2022-01-05	Warnings	Exact identifier unii: QTT17582CB
Lung Drops	BELLADONNA, IPECACUANHA, LOBELIA INFLATA, QUEBRACHO, ANTIMONIUM TARTARICUM, BLATTA ORIENTALIS, NAPHTHALINUM, NATRUM SULPHURICUM, PULSATILLA, RUMEX CRISPUS, MERCURIUS SOLUBILIS, ADRENALINUM.	Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics	684459e3-d6ae-4f7f-b823-539cbb9445c1	2021-12-29	Warnings	Exact identifier unii: YKH834O4BH
Joette Calabrese Survivalist Kit	ABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIP	OHM PHARMA INC.	1ac2a2c4-704e-4efa-aa44-acc71d300f70	2021-12-29	Warnings	Exact identifier unii: QTT17582CB
OHM Pituitarum Complex	ADRENAL GLAND, ADRENOCORTICOTROPHIN, CEREBRUM, LIVER GLAND, PITUITARUM POSTERIUM GLAND, PLACENTA, THYROIDINUM.	OHM PHARMA INC.	69eaabac-dca6-481c-b10e-bf8759a657f7	2021-12-29	Warnings	Exact identifier unii: YKH834O4BH
Adrenalinum	ADRENALINUM	OHM PHARMA INC.	a2a444fa-4337-42e3-bb31-2289c42f057e	2021-12-29	Warnings	Exact identifier unii: YKH834O4BH
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	d763511e-f1a7-4014-94b9-f7ad8f023ff4	2021-12-02		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	cf9f43a0-c750-4cf0-ac49-176ab2105aab	2021-12-02		Exact identifier unii: XF417D3PSL
InterSol	PLATELET ADDITIVE 3	Fenwal, Inc.	e4f06c0b-7cb1-49c9-97a4-2cfc21298495	2021-11-16	Warnings, Adverse reactions	Exact identifier unii: GR686LBA74
Solucion InterSol	SOLUCION ADITIVA PARA PLAQUETAS 3	Fenwal, Inc.	d5eaf5f4-67d3-4475-af9a-f5b0f882f5d1	2021-10-04	Warnings, Adverse reactions	Exact identifier unii: GR686LBA74
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	ba082c2f-64f4-419d-9c88-74f203316e17	2021-08-25	Warnings, Adverse reactions	Exact identifier unii: EC2CNF7XFP
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Fungisode	ARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHUR	Seroyal USA	55c5dfc4-3757-6ac2-e054-00144ff88e88	2021-07-22	Warnings	Exact identifier unii: QTT17582CB
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Candid- Y	ADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.	Newton Laboratories, Inc.	c68c9c20-3a07-16df-e053-2a95a90a0cbc	2021-02-01	Warnings	Exact identifier unii: YKH834O4BH
Candid-Y	ADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.	Newton Laboratories, Inc.	c68ea9c3-f95c-dbcd-e053-2995a90a9aeb	2021-02-01	Warnings	Exact identifier unii: YKH834O4BH
Candid-Y	ADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.	Newton Laboratories, Inc.	c6a37dbe-3092-5ecf-e053-2a95a90a7c39	2021-02-01	Warnings	Exact identifier unii: YKH834O4BH
Epinephrine	EPINEPHRINE	Teva Pharmaceuticals USA, Inc.	04f07f15-55e2-411b-abb8-07eab37f5664	2021-01-31	Warnings, Adverse reactions	Exact identifier unii: YKH834O4BH

Reported adverse events (FAERS/openFDA)#

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