FDA.reportPublic FDA data

NDC 59368-367 - 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
59368-367
Package NDCs from labels
59368-367-01
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
59368-367NICOTINE 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 13 of 63 · 1,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Members Mark NicotineNICOTINE POLACRILEXSam's West Incbb8ec4c2-7f1a-4069-9677-8bf645d18e322026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
BLIPNICOTINE POLACRILEXBlip Products, Inc.ad5fc90e-d3b4-4701-bfd8-1cda9087d09a2026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
dg health nicotineNICOTINE POLACRILEXDolgencorp Inc64b2982d-491e-42e7-b65e-7abf5530b9352026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltd26edb714-656d-49ca-b875-28972c490e5f2026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
Mag-Al PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONECardinal Health 107, LLC08df7403-9ee3-4a43-a151-c1a6ef7a75492026-06-10WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAmerisourceBergen (Good Neighbor Pharmacy) 4612233bee4db-d4aa-4c72-8eeb-46ff374a92a62026-06-10WarningsExact identifier
unii: 92RU3N3Y1O
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLCa7e3da43-693b-44df-8566-4847edae9d612026-06-10WarningsExact identifier
unii: 6M3C89ZY6R
Gas ReliefSIMETHICONEP & L Development, LLCf4526eba-e6d0-44de-99ea-4af7a6dba1992026-06-10WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
unii: 92RU3N3Y1O
Tums Chewy Bites with Gas ReliefCALCIUM CARBONATE AND SIMETHICONEHaleon US Holdings LLC6d7be7e4-4bff-4cfd-bbbe-df412ac9db102026-06-09WarningsExact identifier
unii: 92RU3N3Y1O
SIMETHICONESIMETHICONEYYBA50250112-933c-ffb1-e063-6394a90aaafb2026-06-09WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXMeijer Distribution Incdc6b806a-f571-4d33-9b93-3dcd21ad02602026-06-09WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC63ac801f-02ed-43a1-a2a8-2ad35d8fd7a92026-06-09WarningsExact identifier
unii: 6M3C89ZY6R
MedlineDIMETHICONEMedline Industries, LP3c448cf7-8ca5-c7f7-e063-6294a90a75ff2026-06-08WarningsExact identifier
unii: 92RU3N3Y1O
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC90f2da70-c58f-44fb-bdbd-5c95440c11982026-06-08WarningsExact identifier
unii: 6M3C89ZY6R
INFANTS GAS RELIEFSIMETHICONEMollec Inc53705dbc-daca-2214-e063-6294a90a10972026-06-04WarningsExact identifier
unii: 92RU3N3Y1O
Childrens Simethicone DropsCHILDRENS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma6e26ffbe-4c5b-4689-99bc-88b39ed40a252026-06-04WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXRite Aid Corporation8b24aefd-1881-4126-9188-29896a17a06d2026-06-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Stop Smoking AIDNICOTINEGuangxi Keyun E-commerce Co., Ltd.4d724a5a-425e-e441-e063-6294a90a761e2026-06-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Stop Smoking AIDNICOTINEGuangxi Keyun E-commerce Co., Ltd.4d70b8f1-31ab-4aa1-e063-6294a90a13a92026-06-03WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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