FDA.reportPublic FDA data

NDC 59368-355-01 - Nicotine Transdermal System Step 3

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
59368-355
Requested NDC
59368-355-01
Package NDCs from labels
59368-355-01
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 Step 3 - Praxis, LLCPraxis, LLC2023-01-01HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59368-355NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250426_33882cd8-810c-00cd-e063-6394a90a40d1.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 52 of 63 · 1,245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simethicone 125 mgSIMETHICONEProficient Rx LP078ef54e-96b2-4e2f-bebc-9b9bcda1f90a2024-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAdvanced Rx LLC72de768c-c011-433b-be27-f1978d18f7d82024-08-30WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAdvanced Rx LLC57d31610-c658-49cf-9de3-01e8143aeace2024-08-30WarningsExact identifier
unii: 92RU3N3Y1O
QCH Maximum Strength Antacid 516ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.1794c35a-79c5-48c2-e063-6394a90a6d292024-08-28WarningsExact identifier
unii: 92RU3N3Y1O
QCH Regular Strength Antacid 509ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17947ccd-6f11-d4cd-e063-6294a90a108a2024-08-27WarningsExact identifier
unii: 92RU3N3Y1O
Regular Strength Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17dfe539-923b-e623-e063-6294a90a041f2024-08-27WarningsExact identifier
unii: 92RU3N3Y1O
QCH Extra Strength Gas Relief Cherry Flavor 134CHRSIMETHICONEChain Drug Marketing Association Inc.17e3300c-3d31-b7e1-e063-6294a90af0822024-08-27WarningsExact identifier
unii: 92RU3N3Y1O
Quality Choice Infants Non-staining Gas reliefSIMETHICONEChain Drug Marketing Association Inc.17e181e5-6527-54d0-e063-6294a90addc22024-08-23WarningsExact identifier
unii: 92RU3N3Y1O
nicotine miniNICOTINE POLACRILEXWalgreen Company4a08b910-5479-49f5-abbe-ca68949efb242024-08-22WarningsExact identifier
unii: 6M3C89ZY6R
QUALITY CHOICE Maximum Strength Gas Relief SoftgelSIMETHICONEChain Drug Marketing Association, Inc.462fdb9a-d685-4772-9233-6c43db9382cc2024-08-16WarningsExact identifier
unii: 92RU3N3Y1O
Nicorette OriginalNICOTINE POLACRILEXHaleon US Holdings LLC673fd19f-69b3-4f73-b9b4-18b5f4cbf69c2024-08-13WarningsExact identifier
unii: 6M3C89ZY6R
Nicorette Fruit ChillNICOTINE POLACRILEXHaleon US Holdings LLCa0206139-59c6-44c3-963c-8cb5f2d690752024-07-29WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine transdermal system step 3NICOTINERite Aid Corporationd2e32434-ec58-943e-dbeb-8e73315315952024-07-26WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine transdermal system step 3NICOTINEThe Kroger Co.13cdd780-4196-685b-3cab-f9694a3276182024-07-25WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Step 3NICOTINE TRANSDERMAL SYSTEM PATCHDr. Reddy's Laboratories Inc.051be7ae-6504-c2d8-7424-2e328e4fcfc22024-07-25WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine transdermal system step 2NICOTINEChain Drug Marketing Association INCdf1348cb-0d15-7e4b-921c-d8764c858e662024-07-25WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine transdermal system step 1NICOTINEDOLGENCORP, LLC81e55db2-897e-e567-5743-63179783291a2024-07-25WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine transdermal system step 3NICOTINEWalgreens Companyde471db4-b332-0490-198d-d354802728742024-07-25WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine transdermal system step 3NICOTINEDr. Reddy's Laboratories Inc.3a68eb70-0548-fa6f-8b1c-375e8799f24f2024-07-24WarningsExact identifier
unii: 6M3C89ZY6R
Anti Diarrheal Anti GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEKroger Company9c7db942-c8cb-493a-a96f-452b8dfebfc62024-07-23WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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