Nicorette

Product NDC
0135-0225
11-digit product format
001350225
Labeler code
0135
Product ID
0135-0225_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
NDA018612
Marketing category
NDA
Marketing start
2009-06-29
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0135-0225DDiscontinued by firm2026-08-17
excluded packagepackage0135-02250135-0225-02DDiscontinued by firm2026-08-17
excluded packagepackage0135-02250135-0225-03DDiscontinued by firm2026-08-17
excluded packagepackage0135-02250135-0225-08DDiscontinued by firm2026-08-17
excluded packagepackage0135-02250135-0225-14DDiscontinued by firm2026-08-17
excluded packagepackage0135-02250135-0225-15DDiscontinued by firm2026-08-17
excluded packagepackage0135-02250135-0225-17DDiscontinued 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 2 · 81 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 packagepackage0135-0225-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0135-0225-17d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0135-0225-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0135-0225-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0135-0225-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0135-0225-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0135-0225-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0135-0225-17f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0135-0225-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0135-0225-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0135-0225-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0135-0225-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0135-0225-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0135-0225-172ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0135-0225-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0135-0225-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0135-0225-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0135-0225-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0135-0225-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0135-0225-17a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0135-0225-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0135-0225-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0135-0225-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0135-0225-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0135-0225-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0135-0225-17cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0135-0225-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0135-0225-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0135-0225-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0135-0225-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0135-0225-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0135-0225-17cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0135-0225-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0135-0225-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0135-0225-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0135-0225-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0135-0225-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0135-0225-17302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0135-0225-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0135-0225-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0135-0225-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0135-0225-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0135-0225-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0135-0225-17ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0135-0225-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0135-0225-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0135-0225-15ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0135-0225-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0135-0225-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0135-0225-170efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0135-0225-020efc9e666f02…f202fb6c5f17…

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0225-02EA - Each0135-02254575fe06-0df7-480f-b888-67f45c9a939b12012-07-24
0135-0225-03EA - Each0135-02251fd63694-cabc-47a0-af5b-711abf35535512012-07-24

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0225-02001350225021 BLISTER PACK in 1 CARTON (0135-0225-02) > 100 GUM, CHEWING in 1 BLISTER PACK1 blister pack2009-06-290000-00-00NoNoCurrent
0135-0225-17001350225172 CARTON in 1 PACKAGE (0135-0225-17) > 10 BLISTER PACK in 1 CARTON > 10 GUM, CHEWING in 1 BLISTER PACK2 carton2014-08-010000-00-00NoNoCurrent