Home NDC 0135-0226-17 Nicorette
Product NDC 0135-0226
Requested package NDC 0135-0226-17
11-digit product format 001350226
Labeler code 0135
Product ID 0135-0226_1107242e-6fb9-48c7-a01a-f299b1c90177
Type HUMAN OTC DRUG
Nonproprietary name nicotine polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application NDA020066
Marketing category NDA
Marketing start 2009-06-29
Marketing end 0000-00-00
Substance NICOTINE
Active strength 4 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020066-002 NICORETTE NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 N020066-003 NICORETTE (MINT) NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 N020066-004 NICORETTE NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N020066-002 8323683 2028-04-30 Drug product 2013-01-03
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020066-003 NICORETTE (MINT) EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020066-004 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020066-002 NICORETTE EQ 4MG BASE GUM, CHEWING / BUCCAL RLD, RS 1996-02-09 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020066-002 8323683 2028-04-30 Drug product 2013-01-03 e64feba35796…
FDA-Initiated Inactive NDC Indexing# 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 1 of 1 · 7 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0135-0226-17 00135022617 2 CARTON in 1 PACKAGE (0135-0226-17) > 10 BLISTER PACK in 1 CARTON > 10 GUM, CHEWING in 1 BLISTER PACK 2 carton 2014-08-01 0000-00-00 No No Current