FDA.reportPublic FDA data

NDC 59368-357-01 - Nicotine Transdermal System

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
59368-357
Requested NDC
59368-357-01
Package NDCs from labels
59368-357-02, 59368-357-01
Manufacturer
Praxis, LLC
Effective date
2023-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine Transdermal System - Praxis, LLCPraxis, LLC2023-01-01HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59368-357NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [PRAXIS, LLC]2Unmatched20250426_33887d03-4b52-324f-e063-6394a90a52aa.zip

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 63 of 63 · 1,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.99eda7db-ce40-446f-e053-2995a90a95aa2020-12-07WarningsExact identifier
unii: 6M3C89ZY6R
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
unii: 92RU3N3Y1O
Anti-GasSIMETHICONEMarc Glassman, Inc.e99f2041-2543-4331-9f54-9eea179f94d22020-10-06WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXMeijer Distribution Incdc70703e-2c55-4178-a5d5-50f762ab64922019-04-24WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXMeijer Distribution Inc1d2cfb36-2d94-468c-8da1-6b6999b07d7b2019-04-18WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINEH E B98633912-74d8-49db-a03e-4a3f882297ac2019-04-17WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINEH E B691f3f8d-7242-4855-b80b-4d5af0490b372019-04-16WarningsExact identifier
unii: 6M3C89ZY6R
Oatmeal Skin Relief Calming . 8ozDIMETHICONERejoice International Inc.8384dc52-ba36-da3d-e053-2a91aa0a4f402019-03-07WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAdvance Pharmaceutical Inc.531b9850-c93e-4a0c-bd1c-7da33d752d802018-12-17WarningsExact identifier
unii: 92RU3N3Y1O
SimethiconeSIMETHICONEAdvance Pharmaceutical Inc.e11928e8-b9db-43c5-972b-33b325090dfc2018-12-17WarningsExact identifier
unii: 92RU3N3Y1O
signature care nicotineNICOTINE POLACRILEXSafeway22010ed8-7fa6-402a-a314-523538183a552018-11-01WarningsExact identifier
unii: 6M3C89ZY6R
signature care nicotineNICOTINE POLACRILEXSafeway664c3faf-7cab-4bda-8987-07acb8e1142b2018-10-31WarningsExact identifier
unii: 6M3C89ZY6R
exchange select nicotineNICOTINE POLACRILEXArmy & Air Force Exchange Servicee926cf6f-305a-4912-be07-a45bb79058222018-09-21WarningsExact identifier
unii: 6M3C89ZY6R
Heartburn Plus Gas Relief Chewable Multi SymptomCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEWALGREEN CO.2c02e195-9c17-4ddc-80c2-52e51ae9eba02018-01-01WarningsExact identifier
unii: 92RU3N3Y1O
berkley and jensen nicotineNICOTINE POLACRILEXBJWC357123fc-0972-4683-ab52-f95d46c1b6c92017-11-09WarningsExact identifier
unii: 6M3C89ZY6R
SimethiconeSIMETHICONERichmond Pharmaceuticals, Inc.f4be1c0d-01fc-4681-9068-905ed31845342017-10-30WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONECVSd97cd600-6fc4-4d39-9e41-344e446465062017-08-09WarningsExact identifier
unii: 92RU3N3Y1O
ARGAN AIR WATER BANG ESSENCEDIMETHICONEPioom Cosmetic Co.,ltd34e79668-0710-5753-e054-00144ff88e882016-06-08WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONESafewayd36b56a4-06f0-47ff-8add-4c327d60be222016-01-21WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONESafeway14a9fb00-707a-4b55-a060-82ad53a806e32016-01-08WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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