FDA.reportPublic FDA data

NDC 59368-358-01 - 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
59368-358
Requested NDC
59368-358-01
Package NDCs from labels
59368-358-01
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
59368-358NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250426_33887d11-d279-60b5-e063-6294a90a4466.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 14 of 63 · 1,245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nicotineNICOTINE POLACRILEXCVS Pharmacy4bc94e0b-189f-47b0-826c-2ccf6c4a0e3a2026-06-01WarningsExact identifier
unii: 6M3C89ZY6R
REGULAR STRENGTH ANTACID/ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals, Inc.52e75fe4-f04f-31da-e063-6294a90a1e4f2026-05-28WarningsExact identifier
unii: 92RU3N3Y1O
BLIPNICOTINE POLACRILEXBlip Products, Inc.e48ba1fe-a9ad-4ff3-8f73-e08ae40724542026-05-27WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC8b6d7617-ce92-4bad-9f38-81a7f2e9cfa32026-05-27WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXRite Aid Corporationec88f367-ea8d-4bb9-80a6-71ba68412d382026-05-27WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXRite Aid Corporationf1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c2026-05-27WarningsExact identifier
unii: 6M3C89ZY6R
BLIPNICOTINE POLACRILEXBlip Products, Inc.40e2b0e1-e049-4ec5-a4a8-138ad80b84202026-05-27WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRite Aid Corporation9e411b49-c8c4-43f8-a402-5ca2d96db1312026-05-27WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companydd334b2c-bbae-48e7-8f3d-2706d325f6002026-05-26WarningsExact identifier
unii: 6M3C89ZY6R
Gas ReliefSIMETHICONECVS PHARMACY, INC4ff77b4c-9616-4341-9bf8-eca301345a5f2026-05-21WarningsExact identifier
unii: 92RU3N3Y1O
quitine nicotineNICOTINE POLACRILEXQUITINE LLC88e49664-1f09-431c-a96a-92605b79c8122026-05-20WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMIngenus Pharmaceuticals, LLC0c25e8b8-7202-459b-85ac-0d757f344b342026-05-20WarningsExact identifier
unii: 6M3C89ZY6R
Phazyme UltimateSIMETHICONEC.B. Fleet Company, Inc.c8e9f6ac-2db2-4d21-a4b1-5ca6c31056622026-05-20WarningsExact identifier
unii: 92RU3N3Y1O
good sense anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEL. Perrigo Company2cda08a8-3f5e-430c-84a3-d29b97d647af2026-05-20WarningsExact identifier
unii: 92RU3N3Y1O
quitine nicotineNICOTINE POLACRILEXQUITINE LLC302f4785-77e6-433f-83d9-d0d2618d5ef22026-05-20WarningsExact identifier
unii: 6M3C89ZY6R
AFTER CAREDIMETHICONEMerz North Americac19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae2026-05-20WarningsExact identifier
unii: 92RU3N3Y1O
quitine nicotineNICOTINE POLACRILEXQUITINE LLC426e7bbc-cf58-4be0-a8e5-30a8f7ca5b482026-05-20WarningsExact identifier
unii: 6M3C89ZY6R
quitine nicotineNICOTINE POLACRILEXQUITINE LLC486400cd-f2ef-4e14-8cf7-37954e1ed4d42026-05-20WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PatchNICOTINEGuangzhou Yunzhen Trading Co., Ltd.5237a533-e87f-87af-e063-6294a90a551a2026-05-19WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Polacrilex originalNICOTINE POLACRILEXWalgreensf759d9b2-35e0-4b88-9219-4c0e483af5c42026-05-19WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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