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 35 of 38 · 758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.8679e9ab-8610-47f1-be0e-66897f99881d2023-07-14WarningsExact identifier
unii: 45P3261C7T
equate nicotineNICOTINE POLACRILEXWALMART INC.0f625e1a-be08-4460-a588-8b42282ac1212023-06-15WarningsExact identifier
application number: ANDA077007
unii: 6M3C89ZY6R
topcare nicotineNICOTINE POLACRILEXTopco Associates LLC872d8ba6-881c-49f2-9848-1ed3eed768602023-06-15WarningsExact identifier
application number: ANDA077007
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreen Companyd2572335-9c54-4745-9a11-eb9b8d34d0cd2023-06-14WarningsExact identifier
unii: 6M3C89ZY6R
AllerforceCHONDRUS CRISPUS, GLYCYRRHIZA GLABRA, SARSAPARILLA, ZINGIBER OFFICINALE, ADRENALINUM, ALLIUM CEPA, ARALIA RACEMOSA, ARSENICUM ALBUM, CALCAREA CARBONICA, CANTHARIS, IODIUM, NATRUM CARBONICUM, RHUS TOX,BioActive Nutritional, Inc.667036a4-2a89-45c3-a7cc-4b37d735fa4a2023-06-05WarningsExact identifier
unii: 45P3261C7T
Kirkland Signature NicotineNICOTINECostco Wholesale Company0888a974-a8ba-4cb3-996f-c8abfcb90a6f2023-06-01WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXWalgreen Company8af06c23-80b7-4559-b594-a3a02297306d2023-05-28WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Kirkland Signature NicotineNICOTINECostco Wholesale Company33098a72-9146-4547-9d0b-ff28c8c800302023-05-26WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
kirkland signature quit 2NICOTINE POLACRILEXCostco Wholesale Companycb462e10-124e-4ea3-9261-8c1fc7a9e1a62023-05-18WarningsExact identifier
application number: ANDA077007
rxcui: 359817
unii: 6M3C89ZY6R
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companycd1c3493-242c-4981-8561-ebbea938628f2023-05-12WarningsExact identifier
application number: ANDA077007
unii: 6M3C89ZY6R
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: C269C4G2ZQ
Nicotine MiniNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122ab184645-6fff-40cf-9859-4b8dec9098b22023-03-20WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122ab1df1b4-a831-4de2-be87-38b9cd589db92023-03-20WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Nicotine transdermal system step 3NICOTINEA-S Medication Solutions798a66fa-25d8-4713-b25f-56875431e37d2023-03-02WarningsExact identifier
unii: 6M3C89ZY6R
Natrum carbonicumSODIUM CARBONATEBoiron864414b8-9568-7580-e053-2a91aa0a231d2023-01-05Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron8644c5d1-4db3-fac8-e053-2a91aa0a8d6d2023-01-05Exact identifier
unii: 45P3261C7T
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0315c9e-8922-c0b5-e053-2a95a90ae54e2022-12-19WarningsExact identifier
unii: 45P3261C7T
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f031e256-fca5-3939-e053-2995a90a4fe62022-12-19WarningsExact identifier
unii: 45P3261C7T
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0328097-e5d2-3532-e053-2a95a90a93f02022-12-19WarningsExact identifier
unii: 45P3261C7T

Reported adverse events (FAERS/openFDA)#

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