Home DailyMed 2111fe2e-defe-4d1d-80d4-c240edcb3376 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:18:24 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N018612-002 NICORETTE NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 N018612-003 NICORETTE (MINT) NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 N018612-004 NICORETTE NICOTINE POLACRILEX EQ 2MG 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 N018612-002 8323683 2028-04-30 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 · 129 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 2026-09-14 22:38:34 2026-08 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018612-003 NICORETTE (MINT) EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1998-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018612-004 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 2000-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018612-002 NICORETTE EQ 2MG BASE GUM, CHEWING / BUCCAL RLD 1996-02-09 301d65b070ca…
Observed Orange Book patent history# Patent history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N018612-002 8323683 2028-04-30 2013-01-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018612-002 8323683 2028-04-30 2013-01-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018612-002 8323683 2028-04-30 2013-01-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018612-002 8323683 2028-04-30 2013-01-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018612-002 8323683 2028-04-30 2013-01-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018612-002 8323683 2028-04-30 2013-01-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018612-002 8323683 2028-04-30 2013-01-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018612-002 8323683 2028-04-30 2013-01-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018612-002 8323683 2028-04-30 2013-01-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018612-002 8323683 2028-04-30 2013-01-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018612-002 8323683 2028-04-30 2013-01-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018612-002 8323683 2028-04-30 2013-01-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018612-002 8323683 2028-04-30 2013-01-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018612-002 8323683 2028-04-30 2013-01-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018612-002 8323683 2028-04-30 2013-01-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018612-002 8323683 2028-04-30 2013-01-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018612-002 8323683 2028-04-30 2013-01-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018612-002 8323683 2028-04-30 2013-01-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018612-002 8323683 2028-04-30 2013-01-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018612-002 8323683 2028-04-30 2013-01-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018612-002 8323683 2028-04-30 2013-01-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018612-002 8323683 2028-04-30 2013-01-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018612-002 8323683 2028-04-30 2013-01-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018612-002 8323683 2028-04-30 2013-01-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018612-002 8323683 2028-04-30 2013-01-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018612-002 8323683 2028-04-30 2013-01-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018612-002 8323683 2028-04-30 2013-01-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018612-002 8323683 2028-04-30 2013-01-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018612-002 8323683 2028-04-30 2013-01-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018612-002 8323683 2028-04-30 2013-01-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018612-002 8323683 2028-04-30 2013-01-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018612-002 8323683 2028-04-30 2013-01-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018612-002 8323683 2028-04-30 2013-01-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018612-002 8323683 2028-04-30 2013-01-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018612-002 8323683 2028-04-30 2013-01-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018612-002 8323683 2028-04-30 2013-01-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018612-002 8323683 2028-04-30 2013-01-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018612-002 8323683 2028-04-30 2013-01-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018612-002 8323683 2028-04-30 2013-01-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018612-002 8323683 2028-04-30 2013-01-03 f41ea6bd6efb…
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.