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 21 of 63 · 1,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dynashield with DimethiconeZINC OXIDEDynarex Corporationb5dcf9e8-4689-4a08-ae73-3a859b4cbffe2026-03-26WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine PolacrilexNICOTINE POLACRILEXChain Drug Consortium, LLC9c115cd5-1952-4f1e-8e88-27f2c528e91f2026-03-26WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreensdda17eef-cd75-4c82-b468-09111298282d2026-03-25WarningsExact identifier
unii: 6M3C89ZY6R
Mentholatum Natural Ice Protect Plus SPF 30 Protect Plus SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company3804a14b-be7c-a973-e063-6294a90ac7fc2026-03-25WarningsExact identifier
unii: 92RU3N3Y1O
Softlips Oasis Pineapple CoconutDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companyc504463a-28bf-4161-875f-ef73520931c52026-03-25WarningsExact identifier
unii: 92RU3N3Y1O
Mentholatum Natural Ice Cherry, SPF 15 CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37f2c3a6-7790-c8ec-e063-6294a90ace222026-03-25WarningsExact identifier
unii: 92RU3N3Y1O
Mentholatum Natural Ice - Original, SPF 15 OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37dc44aa-17b2-8721-e063-6294a90a34f62026-03-25WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine PolacrilexNICOTINE POLACRILEXWalgreens826f63b2-fd18-4213-be38-a430d78897cb2026-03-25WarningsExact identifier
unii: 6M3C89ZY6R
Softlips Peppermint SwirlDIMETHICONEThe Mentholatum Company4dbea50e-d82d-c702-e063-6394a90ac6e42026-03-24WarningsExact identifier
unii: 92RU3N3Y1O
Softlips VanillaDIMETHICONEThe Mentholatum Company56551008-a4e0-406f-8403-980d2e6b75a02026-03-24WarningsExact identifier
unii: 92RU3N3Y1O
Mentholatum Natural Ice OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company29220eaa-87cb-4ebe-87db-d36288b3a9e42026-03-24WarningsExact identifier
unii: 92RU3N3Y1O
Selan Plus Zinc OxideSELAN PLUS ZINC OXIDETrividia Manufacturing Solutions, Inc07396c61-1dfd-4be7-bddf-0eb570a184632026-03-24WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength Gas ReliefSIMETHICONEGrocery Outlet, Inc.44672e28-3305-a8cc-e063-6394a90a5fef2026-03-23WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXWalgreensd6c6c753-f604-473c-88b4-b5f83f1dd2932026-03-23WarningsExact identifier
unii: 6M3C89ZY6R
gas reliefSIMETHICONEBIONPHARMA INC.4d7a9507-6f3c-6d15-e063-6294a90a01602026-03-20WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXWalgreens69ffbb37-e26c-4214-8d09-0bbabed253102026-03-20WarningsExact identifier
unii: 6M3C89ZY6R
Gas Relief Extra StrengthSIMETHICONEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ea6e04dd-4f57-4a88-b269-af38732915b32026-03-19WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXDolgencorp, Inc. (DOLLAR GENERAL & REXALL)11e537db-7dc7-4b28-97eb-da70c80d8fe32026-03-19WarningsExact identifier
unii: 6M3C89ZY6R
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.4d658287-358f-d358-e063-6294a90a4bd32026-03-19WarningsExact identifier
unii: 92RU3N3Y1O
NICOTINENICOTINE POLACRILEXHyVee Inc6415ebf4-5b6f-4811-997d-27c76893bc042026-03-19WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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