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 29 of 63 · 1,245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
V Relief SerumDIMETHICONEKindra1cd8a9e9-ac88-1799-e063-6294a90a32782026-01-08WarningsExact identifier
unii: 92RU3N3Y1O
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: 6M3C89ZY6R
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: 6M3C89ZY6R
QUITA COLICOS Gas RELIEF DropsSIMETHICONEDLC Laboratories, Inc.d4b0fa36-5925-4a6f-b3c9-0c785503976f2026-01-07WarningsExact identifier
unii: 92RU3N3Y1O
WOFANLI Quit Smoking Nicotine PatchesNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4582b4e9-0c24-069d-e063-6394a90a6f4b2026-01-05WarningsExact identifier
unii: 6M3C89ZY6R
Loperamide hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEBionpharma Inc.47a779c7-c709-6208-e063-6394a90a6dfa2026-01-05WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONESafeway, Inc.7ecfe412-6a58-4dff-a52e-2e02a03426f92026-01-05WarningsExact identifier
unii: 92RU3N3Y1O
members mark nicotineNICOTINE POLACRILEXSam's West Inc1f1048ab-f161-4f4d-a4dc-a9bd01fc534b2026-01-05WarningsExact identifier
unii: 6M3C89ZY6R
Foster and Thrive NicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC2b1ca577-11a7-4640-89d5-d5a1b0bfa59e2026-01-05WarningsExact identifier
unii: 6M3C89ZY6R
BLIPNICOTINE POLACRILEXBlip Products, Inc.8f5d185b-b6ce-4931-a983-a5a4e0d9d6db2026-01-02WarningsExact identifier
unii: 6M3C89ZY6R
OKeeffes Lip RepairAVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENEThe Gorilla Glue Company/O'Keeffe's Company6805b3e9-77cb-bfee-e053-2991aa0a8d982026-01-01WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone 180 MGSIMETHICONE 180 MGFarmacias De Similares TX LLC4b2166f7-8d98-dd76-e063-6394a90a7f0f2026-01-01WarningsExact identifier
unii: 92RU3N3Y1O
ScarzenDIMETHICONEVillage Pharma LLC1550f4e5-22e2-491f-8184-de65da7234e62026-01-01WarningsExact identifier
unii: 92RU3N3Y1O
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472eafe8-aa7a-f435-e063-6294a90acf6b2025-12-30WarningsExact identifier
unii: 92RU3N3Y1O
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472f5bfc-c676-56da-e063-6294a90a74af2025-12-30WarningsExact identifier
unii: 92RU3N3Y1O
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472ffa66-938f-14e7-e063-6394a90ad0ca2025-12-30WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEH-E-B3f9f6560-312f-44b7-e063-6394a90a1c562025-12-24WarningsExact identifier
unii: 92RU3N3Y1O
Mixed Berry Antacid and Anti-Gas ChewsCALCIUM CARBONATEWalmart Stores41e63d39-bfcb-07a8-e054-00144ff88e882025-12-23WarningsExact identifier
unii: 92RU3N3Y1O
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEMeijer, Inc.419a7333-9743-8e31-e063-6394a90a49742025-12-23WarningsExact identifier
unii: 92RU3N3Y1O
Habitrol Nicotine Polacrilex Gum 4 mg Coated MintNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.ed5722d7-746b-468e-89b5-506055d12bbd2025-12-23WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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