FDA.reportPublic FDA data

NDC 51688-5138 - 535090 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
51688-5138
Package NDCs from labels
51688-5138-5
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2016-06-06
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.2016-06-06MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE MOIETYYKH834O4BH535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X4535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () KIT [SMITHS MEDICAL ASD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0R535090 PER-FIT PERCUTANEOUS DILATIONAL TRACHESTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE () 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 1 of 72 · 1,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.23c8f711-e458-479a-9ab0-dcc851311e242026-09-10Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
unii: V13007Z41A
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
unii: V13007Z41A
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
unii: V13007Z41A
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
unii: V13007Z41A
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
unii: V13007Z41A
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
unii: V13007Z41A
Nerve Guard Nerve ReliefLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated6b78f40f-2a7f-4c49-96af-1a95acbf430f2026-09-04WarningsExact identifier
unii: V13007Z41A
Tree PollenACER NEGUNDO, ACER RUBRUM, ADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, BETULA NIGRA, EUPHRASIA OFFICINALIS, FRAXINUS AMERICANA, HISTAMINUM HYDROCHLORICUM, LIGUSTRUM VULGARE, LIQUIDAMBAR STYRACIFLUA, MORUS ALBA, PINUS STROBUS, POPULUS DELTOIDES, QUERCUS RUBRA, SABADILLA, SALIX NIGRA, SANGUINARIA CANADENSISNaturalCarefeea837e-7ce3-4575-8cb8-451f5385cf972026-09-03WarningsExact identifier
unii: YKH834O4BH
EPINEPHRINEEPINEPHRINEREMEDYREPACK INC.55befbe4-c819-4367-bbe7-de5841786aac2026-09-03Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Lidocaine ViscousLIDOCAINE HYDROCHLORIDEREMEDYREPACK INC.6f8d20d2-6a91-4a5b-bfe8-f1baada384422026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Aplicare Povidone-IodinePOVIDONE-IODINEAplicare Products, LLC7302a2f8-a600-4200-bc4e-309e4c190fe52026-09-02WarningsExact identifier
unii: 85H0HZU99M
Aplicare Povidone-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCb8a23a29-2541-4987-a534-17a6369a6c8d2026-09-02WarningsExact identifier
unii: 85H0HZU99M
HUSTLE BUTTER NUMBINGLIDOCAINE HCL, BENZALKONIUM CHLORIDEH.B.D. DIST. INC.5b4d0390-dac6-4a71-9fdc-5c31543e7c5a2026-09-02WarningsExact identifier
unii: V13007Z41A
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: YKH834O4BH
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma9920daef-b156-4a14-b641-f714191ffb5c2026-09-02Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
EPINEPHRINEEPINEPHRINEREMEDYREPACK INC.5ba14408-c8fb-4734-aad9-ee19696acac22026-08-28Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEREMEDYREPACK INC.f824b48c-7039-4ce1-b3df-b3597aba5beb2026-08-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Povidone-Iodine Topical AntisepticPOVIDONE-IODINEMedline Industries, LPc9036a83-22f5-4a09-b01c-7093d4192c192026-08-28WarningsExact identifier
unii: 85H0HZU99M
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: YKH834O4BH

Reported adverse events (FAERS/openFDA)#

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