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 5 of 38 · 758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXRugby Laboratories0f5af06c-ab1c-48d0-a39f-4d1d7e78ff252026-07-10WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Nicotine Polacrilex Lozenge MintNICOTINE POLACRILEX LOZENGE 2 MGDr. Reddy's Laboratories Inc.836bae74-076b-3c92-dee9-22b8519b529d2026-07-09WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.003b863c-06b0-715d-ccc2-b7da4deac6212026-07-09WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc8c296647-00a1-43d0-acd1-7c1e92f368832026-07-09WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ef9e55d-83e0-4ba5-a905-8cddb0db00192026-07-09WarningsExact identifier
application number: ANDA077007
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.b0fdb36d-4cf5-8a91-3da1-90e3587450f92026-07-09WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Habitrol Lozenge Original FlavorNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.87714b79-05b3-f3c2-6505-5923e4f488712026-07-09WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Habitrol Lozenge CherryNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.5a464242-7d63-141e-808e-c41676cf4b782026-07-09WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inc8cb5577b-48c0-47f8-8979-0ab54d7130452026-07-09WarningsExact identifier
application number: ANDA077007
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.6b0342dd-120f-a16e-098a-dc45b14d3d3a2026-07-09WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
DG HEALTH NICOTINENICOTINE POLACRILEXDolgencorp Incb44f0525-abf6-461d-ae15-40d162021eaa2026-07-01WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal System step 3NICOTINEAmerisourceBergen Drug Corporatione51d2c09-a20f-eb9b-e3e4-013f3e488ab32026-07-01WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC03d9708a-923c-4fd3-ac3d-6ab4a4d8a8042026-06-30WarningsExact identifier
unii: 6M3C89ZY6R
topcare nicotineNICOTINE POLACRILEXTopco Associates LLCc3c52b83-fdbe-4999-b982-37c63462eb7c2026-06-30WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLCf0f79275-c27a-4d35-a79a-53b0905c37612026-06-29WarningsExact identifier
unii: 6M3C89ZY6R
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc768e3f3d-d867-4574-8a5d-07572e2e4a042026-06-29WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E B9bf10dfc-c6df-4cc9-ba79-2dcf874a29042026-06-26WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companyb8cbb6a7-aeb4-48f3-a0ed-7ad8030217522026-06-26WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E Ba1f36614-539f-45db-aad4-1b300c60bf432026-06-26WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E B55defc7f-f91d-46eb-8558-2ab1b69ec6a12026-06-26WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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