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 32 of 63 · 1,260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mini NicotineNICOTINE POLACRILEXMeijer, Inc.084f9d77-b4ab-4328-8ff4-cdc7523daebe2025-12-08WarningsExact identifier
unii: 6M3C89ZY6R
Heartburn and gas fruit chewsCALCIUM CARBONATECVS Pharmacy4a656a9f-8f34-69b7-e054-00144ff8d46c2025-12-07WarningsExact identifier
unii: 92RU3N3Y1O
CVS Mixed Berry Antacid HBG 54ctCALCIUM CARBONATECVS Pharmacye9204edb-e4d9-3975-e053-2995a90ac6a92025-12-07WarningsExact identifier
unii: 92RU3N3Y1O
CVS Mixed Berry Antacid HBG 28ctCALCIUM CARBONATECVS Pharmacye9481d36-3b28-5caf-e053-2a95a90a31212025-12-07WarningsExact identifier
unii: 92RU3N3Y1O
Nicotine MiniNICOTINE POLACRILEXRising Pharma Holdings, Inc.05990040-5bd7-4622-8fe3-2d7573904dfa2025-12-06WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXRising Pharma Holdings, Inc.a3f19365-d0d1-43ad-be15-48dc4320e3612025-12-06WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXRising Pharma Holdings, Inc.e86b9c22-7ee0-4bd0-adfd-a7b087b1dd712025-12-06WarningsExact identifier
unii: 6M3C89ZY6R
Basic Care Berry Antacid HBGCALCIUM CARBONATEAmazon.comc8d4050e-75fd-2445-e053-2995a90a7b0d2025-12-05WarningsExact identifier
unii: 92RU3N3Y1O
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC5d23992f-a010-4604-b64c-94ab6b134e6d2025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
CVS Health Maximum StrengthANTACID AND ANTIGASCVS Pharmacy,Inc.0a13ac81-0c63-48c1-bbb0-f6e67f97b8962025-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Quality Choice Infants Dye Free Gas ReliefSIMETHICONECHAIN DRUG MARKETING ASSOCIATION6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e42025-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Prequel Skin Utility Balm Multi-Purpose Skin ProtectantSKIN PROTECTANT BALMThe Center Brands, LLC57c0b71d-6099-415c-976d-b96d2f73e9d32025-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Alka-Seltzer Kids Tummy ReliefChewsCALCIUM CARBONATE AND DIMETHICONEBayer HealthCare LLC.ba48966e-3762-5fdf-e053-2995a90aeb3d2025-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Softlips CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybececc42-1321-430a-80ef-438060fdcc862025-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Quitine nicotineNICOTINE POLACRILEXQUITINE LLC90232b4e-cbf4-4d03-973a-41f4ebb4e5de2025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
Gold Bond Diabetics Dry Skin Relief Foot CreamDIMETHICONE AND WHITE PETROLATUMGold Bond Co LLC77b8c30b-d5ba-42ce-9313-4ce1b0bce8732025-12-04WarningsExact identifier
unii: 92RU3N3Y1O
quitine mini nicotineNICOTINE POLACRILEXQUITINE LLC0781ddbd-45c4-4191-898a-50c71644965c2025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
QUITINE MINI NICOTINENICOTINE POLACRILEXQUITINE LLCd856379c-6334-4069-8382-ded2f86cf8a42025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
AntiflatulentSIMETHICONEMajor Pharmaceuticalsd321114e-09ac-4252-a6e6-3dbc3a451ee62025-12-03WarningsExact identifier
unii: 92RU3N3Y1O
QC Gas Relief Mint FlavorSIMETHICONEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)26b83259-744b-4711-a32f-9f8fe5d0555b2025-12-03WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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