FDA.reportPublic FDA data

NDC 59368-353-01 - Nicotine Transdermal System Step 3

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
59368-353
Requested NDC
59368-353-01
Package NDCs from labels
59368-353-01
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 Step 3 - Praxis, LLCPraxis, LLC2023-01-01HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59368-353NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250426_33882cd8-810c-00cd-e063-6394a90a40d1.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 · 1,245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Nicotine Stop Smoking AIDNICOTINEGuangxi Keyun E-commerce Co., Ltd.4d7219e6-17a9-b7d9-e063-6394a90a465e2026-06-03WarningsExact identifier
unii: 6M3C89ZY6R
Quad WashDIMETHICONEDynarex Corporation535dc862-6a18-26c9-e063-6294a90a3d4a2026-06-03WarningsExact identifier
unii: 92RU3N3Y1O
Infants Simethicone DropsINFANTS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma235f458e-c275-4bc1-9c0f-e007c40406492026-06-03WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXHyVee Inc7e391e5d-a715-42ae-8c4d-0a7d1a8599892026-06-03WarningsExact identifier
unii: 6M3C89ZY6R
Gas Relief Extra StrengthSIMETHICONECare One (Retail Business Services, LLC.)5e2b25a0-eddf-4d58-927f-bc72c0a92c882026-06-02WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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