FDA.reportPublic FDA data

NDC 59368-366 - 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
59368-366
Package NDCs from labels
59368-366-01
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
59368-366NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250426_3388fe61-3f65-c86e-e063-6294a90ac093.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 34 of 63 · 1,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief Extra StrengthSIMETHICONEMajor Pharmaceuticals4f445be1-220d-4660-abb2-c24cd33e7ca72025-11-19WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Extra StrengthSIMETHICONECardinal Health (Leader) 700004ce6d62c-9321-4b11-94ea-c51a94f351812025-11-19WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEFamily Dollar (FAMILY WELLNESS)04736bb0-58fa-4d6d-ac0a-761c0429f85e2025-11-19WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Extra StrengthSIMETHICONEUnited Natural Foods, Inc. dba UNFIbdd7147b-dcb4-4aa0-a3a1-ec9ceaeec7872025-11-19WarningsExact identifier
unii: 92RU3N3Y1O
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company477689fc-688a-4c76-8c02-35a7a15adc5e2025-11-19WarningsExact identifier
unii: 6M3C89ZY6R
Gas ReliefSIMETHICONEStrategic Sourcing Services LLCfa85df3f-243d-470b-ad28-82512e05fbbe2025-11-19WarningsExact identifier
unii: 92RU3N3Y1O
Equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc27c579b5-1021-4551-9680-bf8978e1d9b42025-11-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAveva Drug Delivery Systems, Inc.55442645-fa9b-4a9b-81e2-345ad062a1242025-11-18WarningsExact identifier
unii: 6M3C89ZY6R
Gas Relief Extra StrengthSIMETHICONEP & L Development, LLC4120832d-6c98-43f6-bdac-c88376c88c302025-11-17WarningsExact identifier
unii: 92RU3N3Y1O
REGULAR STRENGTH ANTACID/ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONERUGBY LABORATORIESb244fce9-9626-e947-e053-2995a90ab8f92025-11-17WarningsExact identifier
unii: 92RU3N3Y1O
SIMETHICONESIMETHICONEGeri-Care Pharmaceuticals, Corpbe96ce05-dd74-4915-9a8f-2a1b34e2f1582025-11-17WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Ultra StrengthSIMETHICONEP & L Development, LLCcc2dd74a-9cdb-4162-9d05-2b9279f4a38e2025-11-17WarningsExact identifier
unii: 92RU3N3Y1O
STPSMK QUIT SMOKING NICOTINE PATCHESNICOTINEGuangzhou Ouruisi Biotechnology Co., Ltd43c1b4e9-39ee-d398-e063-6394a90a71f02025-11-16WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC17b00f7a-50ac-46ac-b172-6c6c35e9ca7b2025-11-15WarningsExact identifier
unii: 6M3C89ZY6R
Gas ReliefSIMETHICONEMeijer Distribution, Inc.7723821e-b2fc-4c9c-a389-05184aaea19f2025-11-15WarningsExact identifier
unii: 92RU3N3Y1O
members mark NicotineNICOTINE POLACRILEXSam's West Incc31c30b9-7431-4b90-b011-f34e499df1922025-11-15WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXWalgreen Companyb1154b04-b3a6-4af9-a933-486c5501d46e2025-11-11WarningsExact identifier
unii: 6M3C89ZY6R
MAXIMUM STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS3ce054f3-2953-5f7d-e054-00144ff8d46c2025-11-11WarningsExact identifier
unii: 92RU3N3Y1O
TopCare Extra Strength Gas Relief Cherry CremeSIMETHICONETOPCO ASSOCIATES LLC4d1701fd-b797-4e95-9004-84d528941e722025-11-10WarningsExact identifier
unii: 92RU3N3Y1O
Arme Scar GelDIMETHICONENanjing Ludejin Corporation Management Co., Ltd42e9a59a-480e-f74a-e063-6294a90a06402025-11-06WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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