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 62 of 63 · 1,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICOTINENICOTINE POLACRILEX MINIAurohealth LLC85f05cc6-ae2e-4338-8c1e-c681c2f908582022-11-03WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEX MINIAurohealth LLCcfe6fb63-2897-4e76-8288-1389f363b3c42022-11-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCardinal Health (Leader) 7000071ee5a44-b451-4ecd-9fe7-8124b4dae1c52022-10-20WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCardinal Health (Leader) 700006edf8c50-d3b9-469a-ad57-37c05e0988622022-10-20WarningsExact identifier
unii: 6M3C89ZY6R
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONECamber Consumer Care Ince2a4af66-1d05-408c-9f11-f2a9f325d75c2022-09-12WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide HCl and SimethiconeLOPERAMIDE HCL AND SIMETHICONEOhm Laboratories Inc.06f99f59-e702-49f1-bb1d-e7cf58c54c302022-08-30WarningsExact identifier
unii: 92RU3N3Y1O
NICOTINENICOTINE POLACRILEXAurohealth LLC810932e0-a982-400a-b43d-b847152f685b2022-06-24WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLCdcc0b057-3d5e-4aeb-ac31-478d7a2f47fa2022-06-24WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLC1909cf25-bce8-4880-abc6-548d28a7285d2022-03-07WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLCfa730ae3-c2b3-4ea4-8e50-f819b205d1682022-03-07WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLCafc71ce1-ded2-4259-a9e1-faca692b90a12022-01-11WarningsExact identifier
unii: 6M3C89ZY6R
Rexall NicotineNICOTINE POLACRILEXDolgencorp, LLC83b053f6-304b-4f9c-8a6d-6649998708b22021-12-15WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC6f73126a-32e5-48b9-8013-6afb0ebe8fd82021-09-28WarningsExact identifier
unii: 6M3C89ZY6R
Gas ReliefSIMETHICONEAllegiant Healthae98861e-6a26-4e0e-a66a-b2738d3cbddd2021-09-24WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAllegiant Health4c79535c-4372-4fd4-a91a-d93617cd581b2021-09-24WarningsExact identifier
unii: 92RU3N3Y1O
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC8cc8de15-5906-4749-99f2-2884c6a1842a2021-09-07WarningsExact identifier
unii: 6M3C89ZY6R
exchange select nicotineNICOTINE POLACRILEXArmy & Air Force Exchange Service0294974c-8d07-4a2e-b929-648c712b6ebe2021-06-01WarningsExact identifier
unii: 6M3C89ZY6R
Loperamide Hydrochloride, SimethiconeLOPERAMIDE HYDROCHLORIDE, SIMETHICONEGuardian Drug Company1b79204e-8a99-455b-84d6-f381fd7d11352021-06-01WarningsExact identifier
unii: 92RU3N3Y1O
exchange select nicotineNICOTINE POLACRILEXArmy & Air Force Exchange Servicec1f1048b-e581-45bf-b344-8e2b0b7488bb2021-05-27WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companyfac52e0d-7a02-451e-a36b-30d49e929d3e2021-03-31WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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