FDA.reportPublic FDA data

NDC 59368-346-01 - 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
59368-346
Requested NDC
59368-346-01
Package NDCs from labels
59368-346-01
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
59368-346NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250425_33778632-3b8a-7eff-e063-6394a90ac83b.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 62 · 1,240 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
NicotrolNICOTINEPharmacia & Upjohn Company LLCacb7d02d-249b-4645-ac1b-8ff9a56dd2442025-05-29Warnings, Adverse reactionsExact identifier
unii: 6M3C89ZY6R
Gas-X Ultimate Strength SoftgelsSIMETHICONEHaleon US Holdings LLC24b777e5-f0b5-400d-8ca9-ae0c04b8503b2025-05-20WarningsExact identifier
unii: 92RU3N3Y1O
QUIT SMOKING Proven PatchesNICOTINEJiashen International Trade Limited35570155-c769-dc4c-e063-6394a90a019d2025-05-17WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEX MINIAurohealth LLC5102e242-4d27-4b1f-8a65-2b52ba3f22762025-05-14WarningsExact identifier
unii: 6M3C89ZY6R
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEATLANTIC BIOLOGICALS CORP.043207dd-5e1c-4c78-b75a-7d341d71b1172025-05-12WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine PolacrilexNICOTINE POLACRILEXAAFES/Your Military Exchanges27308f6b-43b9-4b1d-af6b-7a39b79def032025-05-08WarningsExact identifier
unii: 6M3C89ZY6R
SUKKHI Polyamino Sugar Condensate Massage CreamSUKKHI POLYAMINO SUGAR CONDENSATE MASSAGE CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd34aaf4ef-26dc-f87e-e063-6394a90a9a592025-05-08WarningsExact identifier
unii: 92RU3N3Y1O
AMAZON BASIC CARE NICOTINE POLACRILEXNICOTINE POLACRILEX MINIAmazon.com Services LLC113e54e3-e9c3-4949-e063-6394a90a6fdf2025-05-02WarningsExact identifier
unii: 6M3C89ZY6R
AMAZON BASIC CARE NICOTINE POLACRILEXNICOTINE POLACRILEXAmazon.com Services LLC113e0be9-7edc-4766-e063-6294a90af7522025-05-02WarningsExact identifier
unii: 6M3C89ZY6R
AMAZON BASIC CARE NICOTINE POLACRILEXNICOTINE POLACRILEXAmazon.com Services LLC10ece1fa-f4c2-42ad-e063-6394a90a3a7d2025-05-02WarningsExact identifier
unii: 6M3C89ZY6R
AMAZON BASIC CARE NICOTINE POLACRILEXNICOTINE POLACRILEX MINIAmazon.com Services LLC10ee6816-8155-d590-e063-6394a90a9dea2025-05-02WarningsExact identifier
unii: 6M3C89ZY6R
Diabetic Advanced Healing CreamDIMETHICONENeoteric Cosmetics, Inc.46996845-9398-41d8-bf99-79f6a29bec282025-04-30WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine PolacrilexNICOTINE POLACRILEXLucy Goods, Inc.b97d27d2-a6e1-40da-bdc2-eaf7b88321f62025-04-29WarningsExact identifier
unii: 6M3C89ZY6R
EXTRA STRENGTH GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corpb6223134-8a2e-d1ec-e053-2995a90a90772025-04-28WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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