FDA.reportPublic FDA data

NDC 59368-463-01 - nicotine

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
59368-463
Requested NDC
59368-463-01
Package NDCs from labels
59368-463-01, 59368-463-02
Manufacturer
Sixarp, LLC
Effective date
2026-09-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
nicotine - Sixarp, LLCSixarp, LLC2026-09-03HUMAN OTC DRUG LABEL

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 27 of 38 · 758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Nicotine Polacrilex Gum, Mint FlavorNICOTINE POLACRILEXATLANTIC BIOLOGICALS CORP.62609a8d-bcbe-420c-aed8-edfdf022ff262025-06-27WarningsExact identifier
unii: 6M3C89ZY6R
Aroamas Cot Nicotine Transdermal Patches KitNICOTINE TRANSDERMAL PATCHESPCHEERY LLC38576022-9413-c9af-e063-6294a90afd462025-06-24WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine transdermal systemNICOTINESam's West Inccd9aa56c-ac88-4f9b-9ff9-a9720af6c1a72025-06-10WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine transdermal systemNICOTINETarget Corporationf8d6bf61-6d66-4651-8145-c4cb1d5e443f2025-06-10WarningsExact identifier
unii: 6M3C89ZY6R
Nicorette Cherry PeppermintNICOTINE POLACRILEXHaleon US Holdings LLC35438b53-2760-bcfe-e063-6394a90a65c02025-06-09WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCf350e050-2173-43e0-8738-848382ce07002025-06-04WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
members mark nicotineNICOTINE POLACRILEXSam's West Inc78126814-286e-485f-a4ce-77587f3d77e32025-06-04WarningsExact identifier
application number: ANDA077007
rxcui: 359817
unii: 6M3C89ZY6R
Elsophie Nicotine Patches QuitNICOTINE PATCHES QUIT SMOKINGShenzhen Xinxin Yunhai Technology Co., Ltd.36b63da9-94cc-b52a-e063-6394a90a50292025-06-03WarningsExact identifier
unii: 6M3C89ZY6R
Members Mark NicotineNICOTINE POLACRILEXSam's West Inc36c15917-eceb-4f5a-9021-711956e7b51b2025-06-03WarningsExact identifier
application number: ANDA077007
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINEEXELAN PHARMACEUTICALS, INC.5aeb4f5c-7cc4-4532-b76e-53bdee8e72202025-06-01WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINEA-S Medication Solutions13aa171e-7425-47fc-b618-7759840f06182025-05-30WarningsExact identifier
unii: 6M3C89ZY6R
NicotrolNICOTINEPharmacia & Upjohn Company LLCacb7d02d-249b-4645-ac1b-8ff9a56dd2442025-05-29Warnings, Adverse reactionsExact identifier
unii: 6M3C89ZY6R
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: 45P3261C7T
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: Z0H242BBR1
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
QUIT SMOKING Proven PatchesNICOTINEJiashen International Trade Limited35570155-c769-dc4c-e063-6394a90a019d2025-05-17WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEX MINIAurohealth LLC5102e242-4d27-4b1f-8a65-2b52ba3f22762025-05-14WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXAAFES/Your Military Exchanges27308f6b-43b9-4b1d-af6b-7a39b79def032025-05-08WarningsExact identifier
unii: 6M3C89ZY6R
AMAZON BASIC CARE NICOTINE POLACRILEXNICOTINE POLACRILEX MINIAmazon.com Services LLC113e54e3-e9c3-4949-e063-6394a90a6fdf2025-05-02WarningsExact identifier
unii: 6M3C89ZY6R
AMAZON BASIC CARE NICOTINE POLACRILEXNICOTINE POLACRILEXAmazon.com Services LLC113e0be9-7edc-4766-e063-6294a90af7522025-05-02WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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