FDA.reportPublic FDA data

NDC 59368-367 - 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
59368-367
Package NDCs from labels
59368-367-01
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
59368-367NICOTINE 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 56 of 63 · 1,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Extra Strength Gas Relief CherrySIMETHICONEFamily Dollar Services, Inc.656e6f0d-1fe7-4e58-bff2-569beb91e4652024-02-23WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXWalgreens446c857f-2380-4019-9a82-9fb9ee060d082024-02-21WarningsExact identifier
unii: 6M3C89ZY6R
up and up nicotineNICOTINE POLACRILEXTarget Corporation65a612e8-18d3-49fd-844f-4ccd0210acd32024-02-20WarningsExact identifier
unii: 6M3C89ZY6R
up and up nicotineNICOTINE POLACRILEXTarget Corporationc0c667b8-7384-4970-8f27-f108192c32562024-02-20WarningsExact identifier
unii: 6M3C89ZY6R
Gas ReliefSIMETHICONEBest Choice (Valu Merchandisers Company)23eda70b-ff1e-4b4e-9f9e-034ef101cd682024-02-20WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXWalgreens19bd0eb4-0cd6-4979-bef6-eedbd4d5de882024-02-20WarningsExact identifier
unii: 6M3C89ZY6R
Anti-Gas Ultra StrengthSIMETHICONEBest Choice (Valu Merchandisers Company)f74d9882-cc99-41b6-b851-ce89d28f33df2024-02-15WarningsExact identifier
unii: 92RU3N3Y1O
Blistex Medicated Mint BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc86fc9f3c-e35f-4988-bf19-64d9c6c85ee92024-02-09WarningsExact identifier
unii: 92RU3N3Y1O
Blistex Medicated Berry BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc827365b3-b3a5-4472-9add-f822362c47312024-02-09WarningsExact identifier
unii: 92RU3N3Y1O
Blistex Medicated Lip BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc8b4160ed-8889-4e3a-947f-a56c3324dbbe2024-02-09WarningsExact identifier
unii: 92RU3N3Y1O
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfe04c244-d9b8-2800-e053-6294a90aeedc2024-02-06WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta ClassicCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a4cf29-39ed-87c3-e063-6394a90a49732024-02-05WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Vanilla CaramelCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a66d74-74b4-3f8d-e063-6394a90a7f002024-02-05WarningsExact identifier
unii: 92RU3N3Y1O
Right Remedies Maximum Strength Gas Relief SoftgelSIMETHICONEStrive Pharmaceuticals Inc.032b3a89-1bc4-4f38-ba9e-0a48402153302024-02-05WarningsExact identifier
unii: 92RU3N3Y1O
XtraCare Skin Relief Oatmeal Daily MoisturizingDIMETHICONERejoice International8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc2024-01-29WarningsExact identifier
unii: 92RU3N3Y1O
Good Sense NicotineNICOTINE POLACRILEXA-S Medication Solutionsd84f27e4-c63b-4d04-9e65-bdb1a3594f922024-01-22WarningsExact identifier
unii: 6M3C89ZY6R
EIGHT HOUR NIGHTDIMETHICONEREVLONb3b277f9-565a-636c-e053-2995a90a94d22024-01-12WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Gas Relief SoftgelSIMETHICONECardinal Health 110, LLC. DBA Leader57043cae-a8db-4eff-835c-5995e8aea9242024-01-11WarningsExact identifier
unii: 92RU3N3Y1O
Nicorette 4mg Fruit Chill Gum, Lil Drug StoreNICOTINE POLACRILEXLil' Drug Store Products, Inc.0e85dcfa-d9e1-5fbb-e063-6394a90aeae62024-01-09WarningsExact identifier
unii: 6M3C89ZY6R
Nicorette 4mg White Ice Mint Gum, Lil Drug StoreNICOTINE POLACRILEXLil' Drug Store Products, Inc.0e894f4f-2d41-24c2-e063-6294a90ae26c2024-01-09WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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