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 42 of 63 · 1,245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KO-LANTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp31a6011d-5c61-d0fe-e063-6294a90ac5892025-03-31WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine MiniNICOTINE POLACRILEXPLD Acquisitions LLC DBA Avma Pharma Solutions71db232e-b169-47d0-b269-5e14fa75f3a22025-03-27WarningsExact identifier
unii: 6M3C89ZY6R
SEFUDUN QUIT SMOKING NICOTINE PATCHESNICOTINEShenzhen Shandian Jingling Technology Co., Ltd.314e6f25-8fd0-38ba-e063-6294a90aca8b2025-03-27WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMWalgreens5aadb95f-428c-b637-01f4-50d5866ced0c2025-03-25WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD313b08e2-d764-96da-e063-6294a90ab7052025-03-25WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXWalgreen Company4a81d378-009d-43a9-a895-e371ffa700e92025-03-19WarningsExact identifier
unii: 6M3C89ZY6R
Gold Bond Diabetics Medicated Dry Skin Relief Foot CreamDIMETHICONE, WHITE PETROLATUMChattem, Inc.b951d1cb-b81e-4d7f-9a67-8405daa896672025-03-19WarningsExact identifier
unii: 92RU3N3Y1O
TopCare Max Gas Antacid plus Anti-Gas ChewsSIMETHICONETopCo309e8215-84b0-dd84-e063-6394a90ac4422025-03-18WarningsExact identifier
unii: 92RU3N3Y1O
TopCare Cherry Berry Lime Antacid HBGCALCIUM CARBONATETopCo30a01bf6-28c8-87ae-e063-6394a90a6fb52025-03-18WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD30a977c3-6862-670e-e063-6294a90aeb2f2025-03-18WarningsExact identifier
unii: 6M3C89ZY6R
BLIPNICOTINE POLACRILEXBlip Products, Inc.2f829466-f2fb-43f1-9e82-0d33b50b913a2025-03-17WarningsExact identifier
unii: 6M3C89ZY6R
Gas-X Extra Strength SoftgelsSIMETHICONEHaleon US Holdings LLCfa4a3b07-591b-4445-aa67-b17ba1e67d5c2025-03-14WarningsExact identifier
unii: 92RU3N3Y1O
NicotineNICOTINE POLACRILEXMcKesson Corporation dba SKY Packaging0b6880c8-04e7-418a-98d1-0c7d19e025b32025-03-06WarningsExact identifier
unii: 6M3C89ZY6R
Infants Non staining Gas reliefSIMETHICONERetail Business Services, LLC.1501bee6-4734-4836-8573-54af919d42212025-02-27WarningsExact identifier
unii: 92RU3N3Y1O
Anti-Diarrheal/Anti-GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEDiscount Drug Mart, Inc2e0b3aec-f436-c0fb-e063-6394a90abb512025-02-27WarningsExact identifier
unii: 92RU3N3Y1O
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLCf553374b-c20e-4c92-a8c0-cef0aeda8d1c2025-02-26WarningsExact identifier
unii: 92RU3N3Y1O
Maxi NicotineNICOTINE POLACRILEXCardinal Health (Leader) 70000362b4a04-4a5f-4af6-9cd7-82aa172b7afb2025-02-26WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXThe Kroger Co.8c81c885-1d56-4dca-b9bc-adfc9bf580512025-02-25WarningsExact identifier
unii: 6M3C89ZY6R
SIMETHICONESIMETHICONENuCare Pharmaceuticals,Inc.e07f6acc-1b75-d8eb-e053-2a95a90a7d9b2025-02-24WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength Gas Relief Cherry FlavorSIMETHICONEDiscount Drug Mart, Inc2df821f6-e4b5-89ae-e063-6394a90ad4162025-02-24WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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