FDA.reportPublic FDA data

NDC 59368-347-01 - 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
59368-347
Requested NDC
59368-347-01
Package NDCs from labels
59368-347-02, 59368-347-01
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
59368-347NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250425_3377c01e-241f-9440-e063-6294a90a7110.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 38 of 63 · 1,245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Dimethicone 1 Skin ProtectantDIMETHICONEUniversal Distribution Center LLC2c5b96b9-24d6-4223-a63d-fe83d7c023682025-07-24WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXLucy Goods, Inc.bca1c2ab-2263-429d-9f09-f848dd3d826e2025-07-21WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratories, Inc.150faf42-491f-403b-869b-48edd431d1cc2025-07-18WarningsExact identifier
unii: 6M3C89ZY6R
Medicated Peppermint Lip BalmDIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATEBlistex Inc5d48a6fa-ddce-47c3-9b09-1f3abb6950172025-07-18WarningsExact identifier
unii: 92RU3N3Y1O
Maxi NicotineNICOTINE POLACRILEXRugby Laboratories, Inc.7c2e0872-75f6-4c4f-afff-3579375708de2025-07-18WarningsExact identifier
unii: 6M3C89ZY6R
Gas Relief Ultra StrengthSIMETHICONERugby Laboratories, Inc.24731f4b-ca2b-483f-beed-dfc8104f81332025-07-18WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine MiniNICOTINE POLACRILEXRugby Laboratories, Inc.be17cbe9-43bb-424e-9d91-fba4f02691bb2025-07-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXLucy Goods, Inc.76034dd1-361c-442c-92aa-8fa7cf47a5072025-07-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PatchesNICOTINE PATCHESShenzhen TeLaFaErJiaLuo Technology Co., Ltd.3a1abd26-c0aa-8a65-e063-6294a90ab66e2025-07-17WarningsExact identifier
unii: 6M3C89ZY6R
Aveeno DAILY MOISTURIZINGDIMETHICONEKenvue Brands LLC54a13b85-32b5-439d-a27a-8fba2cf442512025-07-16WarningsExact identifier
unii: 92RU3N3Y1O
good sense nicotineNICOTINE POLACRILEXA-S Medication Solutions3e9a5f94-9db2-4cac-8ab9-50fcedfe0e052025-07-16WarningsExact identifier
unii: 6M3C89ZY6R
Aluminum Hydroxide, Magnesium Hydroxide, and DimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEAmerican Health Packaging23539e7e-a723-460f-892f-dac5bbbb9b162025-07-15WarningsExact identifier
unii: 92RU3N3Y1O
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLCedb0f11a-bdb7-484d-9257-09ff47b0fca42025-07-15WarningsExact identifier
unii: 92RU3N3Y1O
stop smoking aidNICOTINE POLACRILEXPublix Super Markets Inc5f205c02-e3a1-4fa1-8cb6-b4da52662c002025-07-14WarningsExact identifier
unii: 6M3C89ZY6R
NICODERM CQNICOTINEHaleon US Holdings LLC93b2d1b9-83c1-40b5-b6af-90c38c8d6cef2025-07-14WarningsExact identifier
unii: 6M3C89ZY6R
ProCure Moisture Barrier1% DIMETHICONE, 12% ZINC OXIDETwin Med LLC3988c83b-d4eb-1f09-e063-6394a90a45ad2025-07-14WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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