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 40 of 63 · 1,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine MiniNICOTINE POLACRILEXATLANTIC BIOLOGICALS CORP.31e0dadd-2678-4e3c-9e62-e3766c21ce5f2025-06-27WarningsExact identifier
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXATLANTIC BIOLOGICALS CORP.a0fc3eae-9c34-48af-bdd2-d95e91b68a9c2025-06-27WarningsExact identifier
unii: 6M3C89ZY6R
Rugby Nicotine Polacrilex Gum, Original FlavorNICOTINE POLACRILEXATLANTIC BIOLOGICALS CORP.57e08517-4c8a-487a-bfbe-2a43f105f4b92025-06-27WarningsExact identifier
unii: 6M3C89ZY6R
Rugby Nicotine Polacrilex Gum, Mint FlavorNICOTINE POLACRILEXATLANTIC BIOLOGICALS CORP.62609a8d-bcbe-420c-aed8-edfdf022ff262025-06-27WarningsExact identifier
unii: 6M3C89ZY6R
Simethicone 125 mgSIMETHICONEATLANTIC BIOLOGICALS CORP.4ce98db3-c7a6-4627-88c5-9de302a531882025-06-27WarningsExact identifier
unii: 92RU3N3Y1O
GNP Regular Strength Gas ReliefDIMETHICONEATLANTIC BIOLOGICALS CORP.b31257ef-489b-4067-9cc6-8a593d9839582025-06-24WarningsExact identifier
unii: 92RU3N3Y1O
Aroamas Cot Nicotine Transdermal Patches KitNICOTINE TRANSDERMAL PATCHESPCHEERY LLC38576022-9413-c9af-e063-6294a90afd462025-06-24WarningsExact identifier
unii: 6M3C89ZY6R
Silicone Scar CreamDIMETHICONE, ASCORBIC ACID, TOCOPHEROL, PANTHENOL, ALLANTOINYunqi Cosmetics (Shenzhen) Co., Ltd37d02d8c-fbb5-5ba5-e063-6294a90a43ac2025-06-17WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine transdermal systemNICOTINESam's West Inccd9aa56c-ac88-4f9b-9ff9-a9720af6c1a72025-06-10WarningsExact identifier
unii: 6M3C89ZY6R
Diabecin HRLIDOCAINE HCL, BENZALKONIUM CHLORIDEPureTek Corporation36c60fe2-5b7b-83dd-e063-6294a90ad4672025-06-10Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
Nicotine transdermal systemNICOTINETarget Corporationf8d6bf61-6d66-4651-8145-c4cb1d5e443f2025-06-10WarningsExact identifier
unii: 6M3C89ZY6R
Nicorette Cherry PeppermintNICOTINE POLACRILEXHaleon US Holdings LLC35438b53-2760-bcfe-e063-6394a90a65c02025-06-09WarningsExact identifier
unii: 6M3C89ZY6R
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCf350e050-2173-43e0-8738-848382ce07002025-06-04WarningsExact identifier
unii: 6M3C89ZY6R
members mark nicotineNICOTINE POLACRILEXSam's West Inc78126814-286e-485f-a4ce-77587f3d77e32025-06-04WarningsExact identifier
unii: 6M3C89ZY6R
Elsophie Nicotine Patches QuitNICOTINE PATCHES QUIT SMOKINGShenzhen Xinxin Yunhai Technology Co., Ltd.36b63da9-94cc-b52a-e063-6394a90a50292025-06-03WarningsExact identifier
unii: 6M3C89ZY6R
Members Mark NicotineNICOTINE POLACRILEXSam's West Inc36c15917-eceb-4f5a-9021-711956e7b51b2025-06-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINEEXELAN PHARMACEUTICALS, INC.5aeb4f5c-7cc4-4532-b76e-53bdee8e72202025-06-01WarningsExact identifier
unii: 6M3C89ZY6R
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEAmerican Health Packaging2faf291e-1d62-412a-a05e-e992cb7def6a2025-05-30WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEATLANTIC BIOLOGICALS CORP376660a2-becb-48cf-a9f5-6a76a8b8ca702025-05-30WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINEA-S Medication Solutions13aa171e-7425-47fc-b618-7759840f06182025-05-30WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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