FDA.reportPublic FDA data

NDC 51688-6346 - 100/573/000 ULTRAperc Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for 7, 8 and 9mm Tubes Only. Without Tracheostomy Tube.

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
51688-6346
Package NDCs from labels
51688-6346-5
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2013-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lidocaine Hydrochloride and EpinephrineSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.2013-01-23MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
EPINEPHRINEACTIVE MOIETYYKH834O4BH100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
IODINEACTIVE MOIETY9679TC07X4100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
LIDOCAINEACTIVE MOIETY98PI200987100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0R100/573/000 ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR 7, 8 AND 9MM TUBES ONLY. WITHOUT TRACHEOSTOMY TUBE. () KIT [SMITHS MEDICAL ASD, INC.]2

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 24 of 45 · 897 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a27a71-b7b2-12aa-e063-6294a90a312f2025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a7720f-1e74-7578-e063-6394a90a5eae2025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78060-7f0d-c4bd-e063-6294a90ae1522025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78a5c-e3b5-f362-e063-6394a90a08072025-01-15WarningsExact identifier
unii: 2968PHW8QP
D-99ATROPA BELLADONNA, NITROGLYCERIN, LACTIC ACID, UNSPECIFIED FORM, SCROPHULARIA NODOSA, ALOE, RADIUM BROMIDE, POTASSIUM IODIDE, SUS SCROFA BONE MARROW, ZINC, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.dd9c0226-35ea-445a-a570-1ec35551f68d2025-01-13WarningsExact identifier
unii: 2968PHW8QP
D-97ALUMINUM OXIDE, SILVER, SILVER NITRATE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS, CALOMEL, MERCURIC IODIDE, LEAD, LEAD IODIDE, CHELIDONIUM MAJUS, ZINC, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.b2079abb-786c-4f92-8d49-5606c77f7d722025-01-13WarningsExact identifier
unii: 2968PHW8QP
D-114ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACIDDNA Labsf6f7d369-64ef-0ed9-e053-6294a90a40fa2025-01-13WarningsExact identifier
unii: QTT17582CB
D-63EPINEPHRINE, HORSE CHESTNUT, CUPRIC ACETATE, POTENTILLA ANSERINA WHOLE, CLAVICEPS PURPUREA SCLEROTIUM, TOBACCO LEAF, AND VERATRUM ALBUM ROOTDNA Labs, Inc.5278304a-6407-4adc-b1c8-cf0577f3a41a2025-01-13WarningsExact identifier
unii: YKH834O4BH
EVR Povidone lodine WipePOVIDONE LODINEChangzhou Maokang Medical Products Co., Ltd.2b57e301-74e0-e1db-e063-6294a90a6c182025-01-10WarningsExact identifier
unii: 85H0HZU99M
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: XF417D3PSL
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
sterilePOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0658a0c8-f5ec-b380-e063-6394a90afff52025-01-08WarningsExact identifier
unii: 85H0HZU99M
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Foster and Thrive Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMMcKessone5fdfcfd-5340-4929-9f68-2696110cca8e2025-01-07WarningsExact identifier
unii: GR686LBA74
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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