FDA.reportPublic FDA data

NDC 59368-346 - 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
59368-346
Package NDCs from labels
59368-346-01
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
59368-346NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250425_33778632-3b8a-7eff-e063-6394a90ac83b.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 4 of 63 · 1,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICOTINENICOTINE POLACRILEXWalgreen Company5dd116ea-d031-439c-b06c-2f77230bc4462026-08-20WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXAmazon.com Services LLCe40a534e-8083-454d-9667-826bfbac397c2026-08-19WarningsExact identifier
unii: 6M3C89ZY6R
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
nicotineNICOTINE POLACRILEXAmazon.com Services LLCbc1b6b41-d069-470e-90ca-a441ab97f96a2026-08-18WarningsExact identifier
unii: 6M3C89ZY6R
CVS Health Anti gasSIMETHICONECVS PHARMACY352b1d0e-c6dc-491e-b3e2-c3d9dac3213b2026-08-17WarningsExact identifier
unii: 92RU3N3Y1O
CVS Health Infant Gas ReliefSIMETHICONECVS PHARMACY088993c1-31f0-4270-a3df-a585e7c8d5112026-08-17WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Fall Harvest Collection Spiced Apple CiderCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a6040ff-1779-3215-e063-6294a90aaab12026-08-15WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Extra Strength Gas ReliefSIMETHICONE ANTIGASCVSb0fc2f24-cd63-4bb2-b9bb-a73449bcc1692026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Extra StrengthSIMETHICONECVS98db6216-897c-4cf6-a4b7-b913ae3a24962026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Gas reliefSIMETHICONECVSc2a3a978-c957-4453-88b3-53f4e80a24652026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
Mini NicotineNICOTINE POLACRILEXWALMART INC. (see also Equate)286e2768-ad98-43be-a3be-a2db0370f50f2026-08-12WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXWALMART INC. (see also Equate)b49546cd-6cc4-422c-9a72-3a1faf2abcd32026-08-12WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122a33b6ed6-2c75-4bab-98e5-a7f8bea219262026-08-12WarningsExact identifier
unii: 6M3C89ZY6R
WinCo FOODS Extra Strength Gas ReliefSIMETHICONEWINCO FOODS, LLCe2caf17a-a807-47f6-ab85-8e15a4679db42026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED9ba85e0a-bcb7-4803-8d21-0eb93768cb3a2026-08-07WarningsExact identifier
unii: 6M3C89ZY6R
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp55952af9-c3c1-452f-82c8-06f01dc4f0af2026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC1f93571c-4bd2-4272-ab9f-240b7c8a024b2026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXP & L Development, LLC30e00817-75ff-43db-901c-c180e67309012026-08-06WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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