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 41 of 62 · 1,240 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine PolacrilexNICOTINE POLACRILEXLucy Goods, Inc.23ca9fd2-41a0-4210-ad97-62ec84d799072025-04-28WarningsExact identifier
unii: 6M3C89ZY6R
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCc7f32ab1-f6bd-46f5-9852-8eb5b78a33262025-04-25WarningsExact identifier
unii: 6M3C89ZY6R
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCffeb8286-860d-49f5-8df3-724afb4aaad82025-04-25WarningsExact identifier
unii: 6M3C89ZY6R
SILICONE SCAR CreamDIMETHICONE, ASCORBIC ACID, TOCOPHEROL, PANTHENOL, ALLANTOINYunqi Cosmetics (Shenzhen) Co., Ltd338180f7-2449-3d13-e063-6294a90a90832025-04-24WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC21e11fe0-b3b9-42f6-a698-9cdc1a6d82bb2025-04-23WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONE 125 MGNUVICARE LLC5c6352b9-fd8a-4876-b089-e4c1d15cd2642025-04-23WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine transdermal system step 3NICOTINEGolden State Medical Supply, Inc.7c83d507-7e8d-496c-bb9d-63abfa25c7a72025-04-17WarningsExact identifier
unii: 6M3C89ZY6R
Gas Relief - Cherry FlavorSIMETHICONETARGET CORPORATION290fe08d-a0b9-82f7-e063-6394a90a9c752025-04-11WarningsExact identifier
unii: 92RU3N3Y1O
InfantsSIMETHICONEATLANTIC BIOLOGICALS CORP.27fce442-e328-41d2-bab9-87ab21550c042025-04-11WarningsExact identifier
unii: 92RU3N3Y1O
Rolaids Advanced Antacid Anti-gas Mixed BerryCALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONEChattem, Inc.3884c05a-a593-424e-88b3-be962e73488e2025-04-10WarningsExact identifier
unii: 92RU3N3Y1O
good neighbor pharmacy anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmerisource Bergen5dae1247-3ec0-495e-b3f2-1c15551416172025-04-08WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEFSA store INC0199a50f-f367-40e7-8af0-745a959d3fde2025-04-05WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine PolacrilexNICOTINE POLACRILEXDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4af800f9-bcb3-4320-8d32-f1bfd54ee5e92025-04-03WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXMeijer, Inc.8b9f4dfc-9469-449d-9434-656aeccc4fd62025-04-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepack094de23b-d433-487d-8364-6f245c8117c62025-04-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepack3997dda6-89ea-49df-abda-ab420327a4732025-04-03WarningsExact identifier
unii: 6M3C89ZY6R
KO-LANTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp31a6011d-5c61-d0fe-e063-6294a90ac5892025-03-31WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine MiniNICOTINE POLACRILEXPLD Acquisitions LLC DBA Avma Pharma Solutions71db232e-b169-47d0-b269-5e14fa75f3a22025-03-27WarningsExact identifier
unii: 6M3C89ZY6R
SEFUDUN QUIT SMOKING NICOTINE PATCHESNICOTINEShenzhen Shandian Jingling Technology Co., Ltd.314e6f25-8fd0-38ba-e063-6294a90aca8b2025-03-27WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMWalgreens5aadb95f-428c-b637-01f4-50d5866ced0c2025-03-25WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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