Home DailyMed f97c9b19-e284-4eed-9dac-a897df1f14f4 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 03:11:09 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022360-001 NICORETTE NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 N022360-002 NICORETTE NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022360-001 8940772 2029-04-30 Drug product 2015-02-25 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 N022360-002 8501164 2029-06-14 Drug product 2013-09-05
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 3 · 86 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 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 74a2ff9319b5…
Observed Orange Book patent history# Patent history page 1 of 5 · 172 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 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 5bbf6a4d5a75…
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.