FDA.reportPublic FDA data

NDC 51688-6353 - 100/596/090 Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator with Blue Line Ultra Suctionaid Tracheostomy Tube with 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
51688-6353
Package NDCs from labels
51688-6353-5
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2013-01-18
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.2013-01-18MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE MOIETYYKH834O4BH100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X4100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH INTRODUCER () KIT [SMITHS MEDICAL ASD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0R100/596/090 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WITH BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE WITH 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 5 of 46 · 902 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: 2968PHW8QP
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
GUNA-FLAMACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa7bda7eb0-8fd5-42d9-b336-39920bfc964d2026-06-10WarningsExact identifier
unii: 2968PHW8QP
GUNA-ALLERGY TAMMONIUM CARBONATE - APIS MELLIFERA - ARSENIC TRIOXIDE - BLATTA ORIENTALIS - CUPRIC ACETATE - DRIMIA MARITIMA BULB - EPINEPHRINE - GALPHIMIA GLAUCA FLOWERING TOP - HISTAMINE DIHYDROCHLORIDE - LUFFA OPERCULATA - MANGANESE GLUCONATE - ONION - SCHOENOCAULON OFFICINALE SEED - SODIUM CHLORIDE - SUS SCROFA ADRENAL GLAND - SUS SCROFA BRONCHUS - SUS SCROFA NASAL MUCOSA -Guna spafddba85e-2bec-468f-a01a-b71a3aeed9d32026-06-10WarningsExact identifier
unii: YKH834O4BH
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
EpinephrineEPINEPHRINEREMEDYREPACK INC.0172280c-f7d6-4613-9dbd-f94d3ae5825a2026-06-08Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Povidone-IodinePOVIDONE-IODINEH E B4a7a627c-505d-992b-e063-6394a90a54ca2026-06-04Warnings, Adverse reactionsExact identifier
unii: 85H0HZU99M
Povidone IodinePOVIDONE-IODINEAmerisource Bergenf69a5cec-04f2-4028-94c6-1f129d2de5a92026-06-04WarningsExact identifier
unii: 85H0HZU99M
Maokang Povidone-Iodine Paint Solution AntisepticPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd48f81109-3791-46ef-8992-d53b677a51b62026-06-02WarningsExact identifier
unii: 85H0HZU99M
Walgreens Antiseptic First aidPOVIDONE-IODINE SPRAYwalgreens53e96633-0886-6617-e063-6394a90a68aa2026-06-01WarningsExact identifier
unii: 85H0HZU99M
Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)POVIDONE-IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD529b8ad6-081e-0ef8-e063-6294a90a67df2026-05-24WarningsExact identifier
unii: 85H0HZU99M
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINECardinal Health 107, LLC77fd6ee4-108f-4525-8df5-7db9236042ee2026-05-20Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)POVIDONE-IODINEXINXIANG XINDA TECHNOLOGY CO.,LTD51c29301-978a-0d46-e063-6394a90ab9e42026-05-14WarningsExact identifier
unii: 85H0HZU99M
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: XF417D3PSL
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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