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 25 of 63 · 1,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine Polacrilex GumNICOTINE POLACRILEXFertin Pharma A/Sf1774540-7c2f-c60b-e053-2995a90a1ccb2026-02-18WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company788214db-3f78-4209-b3b6-d59cc9be34212026-02-18WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXA-S Medication Solutions83b3b56e-0081-41df-818c-bccc4a996b7f2026-02-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXKroger Company965be729-d417-4ae6-a2a9-ed06c2287d422026-02-17WarningsExact identifier
unii: 6M3C89ZY6R
Daily MoisturizingDIMETHICONEValu Merchandisers Company0cccadd7-11f3-5d1f-e063-6294a90a55c42026-02-16Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC9f2f06c3-4d9b-4c1a-85e3-26f021be5d7c2026-02-16WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXThe Kroger Co.f801e8b2-b789-41f4-b35e-ea3a82d2bb9c2026-02-13WarningsExact identifier
unii: 6M3C89ZY6R
DimethiconeDIMETHICONETopco Associates LLCf37f17f7-f084-4b74-8361-178d2315a4762026-02-13Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
Daily MoisturizingDIMETHICONETopco Associates LLC47e54eee-70e0-4bfa-ae77-d61a6560a9e12026-02-13Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEALTANTIC BIOLOGICAS CORP.05eadb73-4468-4dae-a67b-133d893feed22026-02-13WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONE 180 MGPioneer Life Sciences, LLCf5284b68-f167-41d4-8b2f-ae7bafae0f4c2026-02-13WarningsExact identifier
unii: 92RU3N3Y1O
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC17cf8f3d-6491-4cd8-a447-3c7533f76daf2026-02-13WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC1a916693-6092-4875-872a-7438816c0ddf2026-02-12WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLCcb306cdf-bab5-4b13-986b-21ade4764f002026-02-12WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC440178c0-e9e4-4729-bcd9-f640742c40802026-02-12WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXKroger Company756c6b45-704e-4684-96ba-4df3ef27552c2026-02-12WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC99da90fa-00ff-4c62-91a2-1e434dadaf412026-02-12WarningsExact identifier
unii: 6M3C89ZY6R
topcare nicotine polacrilexNICOTINE POLACRILEXTopco Associates LLCd0403746-f866-42da-ad66-2a686c8bce012026-02-11WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ee883114-35ac-4b81-b8f1-4903d646dd842026-02-11WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXWalgreensb1174e20-e1ad-4c58-8b32-683b7e98fca92026-02-10WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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