FDA.reportPublic FDA data

NDC 59368-368-01 - 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
59368-368
Requested NDC
59368-368-01
Package NDCs from labels
59368-368-01
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
59368-368NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250426_3388fe61-3f65-c86e-e063-6294a90ac093.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 37 of 62 · 1,240 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine MiniNICOTINE POLACRILEXRite Aid Corporation876b80a3-3ea8-4821-9716-c18e245028222025-08-20WarningsExact identifier
unii: 6M3C89ZY6R
Gas ReliefSIMETHICONEBJWC (Berkley & Jensen / BJ's)2f32dde8-502e-eefa-e063-6294a90abf202025-08-19WarningsExact identifier
unii: 92RU3N3Y1O
NICOTINENICOTINE POLACRILEXH E Bf3e395db-61e8-43cb-bf95-8cacd17f5d9a2025-08-13WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXWalgreen Company6c5d786b-8b5a-460a-ae67-c11de9858ad42025-08-10WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreen Companyaf8fadbb-25a7-4ab7-a665-808e4b41978a2025-08-08WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXRite Aid Corporation63a433aa-8c73-47a0-be64-8708f8478fff2025-08-07WarningsExact identifier
unii: 6M3C89ZY6R
ProCure Skin Repair CreamDIMETHICONE 1.5%Twin Med LLC3ba3d3b3-ab13-ea80-e063-6394a90ad4592025-08-05WarningsExact identifier
unii: 92RU3N3Y1O
NICOTINUMNICOTINEBoiron3b8cb10e-6fbb-c542-e063-6294a90a967a2025-08-04Exact identifier
unii: 6M3C89ZY6R
TopCare health EXTRA STRENGTH Gas Relief SOFTGELSIMETHICONETopco Associates LLC2ea0eb22-f679-d136-e063-6294a90a1dfe2025-08-01WarningsExact identifier
unii: 92RU3N3Y1O
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEATLANTIC BIOLOGICALS CORP.ac6a47e7-972f-4b82-96da-89926d345e9f2025-07-31WarningsExact identifier
unii: 92RU3N3Y1O
Nicorette PeppermintNICOTINE POLACRILEXHaleon US Holdings LLC990a4a65-d573-46a9-889d-60afb00189442025-07-31WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAveva Drug Delivery Systems Inc.7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe2025-07-30WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINEStrategic Sourcing Services LLCa08022ff-e412-47f9-8132-318f55528c5c2025-07-30WarningsExact identifier
unii: 6M3C89ZY6R
Maximum Strength Antacid and AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEMeijer, Inc.30a0455d-63e0-95cc-e063-6394a90ada6b2025-07-30WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepackc2627853-945b-42d8-8351-39028e513d772025-07-29WarningsExact identifier
unii: 6M3C89ZY6R
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAARNA USA Inc.9b0fde90-35ae-498e-99cc-d120f1a871822025-07-29WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepack16ece78d-c66e-43c1-953a-f774797ae0972025-07-29WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXLucy Goods, Inc.a18dde9f-700f-4572-a6aa-577dbacdf3142025-07-29WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXLucy Goods, Inc.20aa42c6-14e3-46c5-ba0f-fef217e0b1c22025-07-29WarningsExact identifier
unii: 6M3C89ZY6R
Anti-Diarrheal/Anti-Gas CapletsLOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MGYYBA CORP46f5c653-eec2-4729-8aaa-79f2e188eac32025-07-24WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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