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 15 of 63 · 1,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Nicotine Polacrilex MINTNICOTINE POLACRILEXWalgreens53c5ae28-5638-4217-9080-2bceba9a88852026-05-19WarningsExact identifier
unii: 6M3C89ZY6R
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
unii: 92RU3N3Y1O
gas reliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI2a82a06d-7511-4fc0-b182-9c1774b2af482026-05-15WarningsExact identifier
unii: 92RU3N3Y1O
nicotineNICOTINE POLACRILEXRite Aid Corporation6020abb5-2a4f-4602-8014-e2b4e462c05f2026-05-15WarningsExact identifier
unii: 6M3C89ZY6R
Gas ReliefSIMETHICONECVS PHARMACY, INCb114b07e-6822-465a-9e74-2a741ccb19f72026-05-14WarningsExact identifier
unii: 92RU3N3Y1O
LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Inc92a1d6ce-aff3-45fc-8d98-20c4375aded82026-05-14WarningsExact identifier
unii: 92RU3N3Y1O
Firstcare Gas Relief Simethicone 250 mg Anti-gasSIMETHICONE 250 MGUSpharma Ltd9625a697-fadc-483b-b83a-fa2cc76002ba2026-05-12WarningsExact identifier
unii: 92RU3N3Y1O
Firstcare Gas Relief Simethicone 125 mg Anti-gasSIMETHICONE 125 MGUSpharma Ltde92c9661-01f2-42be-af54-42e60efcae352026-05-12WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine Polacrilex coated cinnamonNICOTINE POLACRILEXCVS Pharmacyd9da6bd9-f655-446d-98b8-5b22db80dad22026-05-12WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company0ac7f87a-63f4-4d74-ba5b-d1444803b1002026-05-11WarningsExact identifier
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC71d1dcd2-e046-49ad-a28a-90e550a711042026-05-11WarningsExact identifier
unii: 6M3C89ZY6R
GOOD SENSE NICOTINENICOTINE POLACRILEXL. Perrigo Company632283a5-c617-4759-8933-7dc015e551c72026-05-11WarningsExact identifier
unii: 6M3C89ZY6R
GOOD SENSE NICOTINENICOTINE POLACRILEXL. Perrigo Company28843e89-9782-42bc-8afb-1059ef44d8f12026-05-11WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Polacrilex originalNICOTINE POLACRILEXCVS Pharmacy62231539-ae9f-4665-ba59-bef047e93d8a2026-05-08WarningsExact identifier
unii: 6M3C89ZY6R
Daily MoisturizingDIMETHICONEAldi, Inc118a1a07-7283-4353-97b5-6ac3b1cc14302026-05-08Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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