NICOTINE POLACRILEX

Product NDC
11673-229
11-digit product format
116730229
Labeler code
11673
Product ID
11673-229_7f0d100b-816a-406b-8c7b-a9e32478e012
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Target Corporation
Application
NDA018612
Marketing category
NDA
Marketing start
2010-02-15
Marketing end
2021-01-05
Substance
NICOTINE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11673-229DDiscontinued by firm2026-08-17
excluded packagepackage11673-22911673-229-04DDiscontinued by firm2026-08-17
excluded packagepackage11673-22911673-229-05DDiscontinued by firm2026-08-17
excluded packagepackage11673-22911673-229-06DDiscontinued by firm2026-08-17

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11673-229-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11673-229-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11673-229-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11673-229-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11673-229-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11673-229-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11673-229-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11673-229-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11673-229-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11673-229-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11673-229-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11673-229-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11673-229-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11673-229-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11673-229-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11673-229-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11673-229-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11673-229-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11673-229-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11673-229-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11673-229-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11673-229-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11673-229-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11673-229-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11673-229-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11673-229-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11673-229-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11673-229-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11673-229-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11673-229-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11673-229-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11673-229-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11673-229-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11673-229-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11673-229-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11673-229-06557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018612-002NICORETTENICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09
N018612-003NICORETTE (MINT)NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23
N018612-004NICORETTENICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N018612-00283236832028-04-302013-01-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018612-003NICORETTE (MINT)EQ 2MG BASEGUM, CHEWING / BUCCALRLD1998-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018612-004NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD2000-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018612-002NICORETTEEQ 2MG BASEGUM, CHEWING / BUCCALRLD1996-02-091e350fbaab3a…

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N018612-00283236832028-04-302013-01-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018612-00283236832028-04-302013-01-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018612-00283236832028-04-302013-01-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N018612-00283236832028-04-302013-01-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018612-00283236832028-04-302013-01-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018612-00283236832028-04-302013-01-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018612-00283236832028-04-302013-01-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018612-00283236832028-04-302013-01-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018612-00283236832028-04-302013-01-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018612-00283236832028-04-302013-01-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018612-00283236832028-04-302013-01-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018612-00283236832028-04-302013-01-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018612-00283236832028-04-302013-01-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018612-00283236832028-04-302013-01-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018612-00283236832028-04-302013-01-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018612-00283236832028-04-302013-01-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018612-00283236832028-04-302013-01-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018612-00283236832028-04-302013-01-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018612-00283236832028-04-302013-01-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018612-00283236832028-04-302013-01-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018612-00283236832028-04-302013-01-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018612-00283236832028-04-302013-01-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N018612-00283236832028-04-302013-01-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018612-00283236832028-04-302013-01-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018612-00283236832028-04-302013-01-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018612-00283236832028-04-302013-01-033f01610625f2…
2019-09-15 20:21 UTC2019-09N018612-00283236832028-04-302013-01-03b00525d2431f…
2019-07-19 19:46 UTC2019-07N018612-00283236832028-04-302013-01-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018612-00283236832028-04-302013-01-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018612-00283236832028-04-302013-01-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018612-00283236832028-04-302013-01-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018612-00283236832028-04-302013-01-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018612-00283236832028-04-302013-01-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018612-00283236832028-04-302013-01-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018612-00283236832028-04-302013-01-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N018612-00283236832028-04-302013-01-03053a50430f4f…
2023-01-26 05:58 UTC2023-01N018612-00283236832028-04-302013-01-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018612-00283236832028-04-302013-01-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018612-00283236832028-04-302013-01-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018612-00283236832028-04-302013-01-03e64feba35796…

DailyMed Socrata Ingredients#

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicorette OriginalNICOTINE POLACRILEXHaleon US Holdings LLC673fd19f-69b3-4f73-b9b4-18b5f4cbf69c2024-08-13WarningsExact identifier
application applno (NDA): 018612
application number: NDA018612
Nicorette Fruit ChillNICOTINE POLACRILEXHaleon US Holdings LLCa0206139-59c6-44c3-963c-8cb5f2d690752024-07-29WarningsExact identifier
application applno (NDA): 018612
application number: NDA018612