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 30 of 63 · 1,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Habitrol Nicotine Polacrilex 2 mg Coated CinnamonNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.6874a9f1-d180-4073-8226-df6e21bcf0b72025-12-23WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Nicotine Polacrilex Gum 4 mg Coated FruitNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.5d3b45d6-97c2-4400-ad09-95a4b21f53242025-12-23WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Nicotine Polacrilex 4 mg Coated CinnamonNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.5c394758-1179-455a-a562-c8e954fb22582025-12-23WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Nicotine Polacrilex Gum 2 mg Coated MintNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.826f0ce5-9862-4f6f-8943-a3f06b07e69f2025-12-22WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Nicotine Polacrilex Gum 2 mg Coated FruitNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.dc811e89-e104-4fdf-aabf-f73d41d85f4c2025-12-22WarningsExact identifier
unii: 6M3C89ZY6R
TENA PROSKIN BARRIERDIMETHICONEEssity HMS North America Inc118bf2df-ee7b-454f-9c0b-2697dc8262682025-12-21WarningsExact identifier
unii: 92RU3N3Y1O
Walgreens Cherry Berry Lime Antacid HBG 54ctCALCIUM CARBONATEWalgreens21da4a30-403d-ec9c-e063-6394a90aa36b2025-12-21WarningsExact identifier
unii: 92RU3N3Y1O
Target Antacid - Anti-Gas Relief ChewsCALCIUM CARBONATETarget964e357c-a8ab-09fa-e053-2a95a90a37c62025-12-20WarningsExact identifier
unii: 92RU3N3Y1O
Target Berry Lime HBG ChewsCALCIUM CARBONATETarget11fba65d-8a81-1227-e063-6294a90a11bd2025-12-20WarningsExact identifier
unii: 92RU3N3Y1O
Target Gas Relief Chews Mixed Berry and StrawberrySIMETHICONETarget11fd2ccd-3a2b-c141-e063-6394a90ab34f2025-12-20WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Simethicone 125mg SoftgelSIMETHICONENUVICARE LLCb774c8e6-e68e-4a13-834d-7eba34c5c3e02025-12-19WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Simethicone 180mg SoftgelSIMETHICONENUVICARE LLC51484644-eb45-4282-91c6-289169bcbaf62025-12-19WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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