FDA.reportPublic FDA data

NDC 51688-6378 - 535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT with SPECIALTY 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
51688-6378
Package NDCs from labels
51688-6378-5
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2013-01-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Povidone-Iodine - Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.2013-01-28MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
EPINEPHRINEACTIVE MOIETYYKH834O4BH535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
IODINEACTIVE MOIETY9679TC07X4535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
LIDOCAINEACTIVE MOIETY98PI200987535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0R535070 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]4

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 3 of 46 · 902 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
unii: 85H0HZU99M
EPINEPHRINEEPINEPHRINEFresenius Kabi USA, LLC4f83895f-638c-4515-af03-7c41ae60a42e2026-07-15Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Aplicare Povidone-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCff19ea2f-d6a0-442f-8f23-d559fc13c5492026-07-14WarningsExact identifier
unii: 85H0HZU99M
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.fa7dedcd-d78b-45f2-9dd7-f273043167d02026-07-14Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
EpinephrineEPINEPHRINEA-S Medication Solutions6e811e28-0199-4df7-a916-5940c632401d2026-07-13Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
EPINEPHRINEEPINEPHRINECIVICA, INC.4a79ad00-405b-4454-a692-7f1daac4adec2026-07-10Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
MedlinePOVIDONE-IODINEMedline Industries, LP1d731a44-f16e-c249-e063-6294a90a39b82026-07-08WarningsExact identifier
unii: 85H0HZU99M
Povidone-IodinePOVIDONE-IODINECARDINAL HEALTH 110, LLC. DBA LEADER4f0d8da5-a75b-acc7-e063-6394a90ae8392026-07-08WarningsExact identifier
unii: 85H0HZU99M
EpinephrineEPINEPHRINEA-S Medication Solutions386519ba-7a44-4edd-9eb1-748419b7a71b2026-07-06Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
TopCare Health Pain ReliefLIDOCAINE HYDROCHLORIDETopco Associates LLC485b0671-da09-19d7-e063-6294a90aca5d2026-07-03WarningsExact identifier
unii: EC2CNF7XFP
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AdrenalinEPINEPHRINEPar Health USA, LLC3b7a4364-668d-4eb2-a20c-04adc35aabe42026-07-01Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.cfbca641-aeee-4dc8-a340-30c53d3b023b2026-07-01Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst76176d50-a987-c9f9-e053-2991aa0aea0f2026-06-29Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH

Reported adverse events (FAERS/openFDA)#

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