Nicorette

Product NDC
0135-0242
11-digit product format
001350242
Labeler code
0135
Product ID
0135-0242_1e6cbf12-d37d-1a4b-e063-6394a90ade6a
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA020066
Marketing category
NDA
Marketing start
2009-09-14
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0135-02420135-0242-03DDiscontinued by firm2026-08-17
excluded packagepackage0135-02420135-0242-14DDiscontinued by firm2026-08-17
excluded packagepackage0135-02420135-0242-15DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050135-0242-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050135-0242-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050135-0242-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260135-0242-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260135-0242-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260135-0242-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310135-0242-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310135-0242-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310135-0242-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280135-0242-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280135-0242-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280135-0242-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210135-0242-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210135-0242-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210135-0242-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100135-0242-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100135-0242-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100135-0242-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310135-0242-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310135-0242-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310135-0242-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200135-0242-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200135-0242-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200135-0242-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100135-0242-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100135-0242-140efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100135-0242-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080135-0242-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080135-0242-14ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080135-0242-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030135-0242-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030135-0242-14367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030135-0242-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090135-0242-14557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090135-0242-15557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090135-0242-03557ba5c1ecfa…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
N020066-002NICORETTENICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09
N020066-003NICORETTE (MINT)NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23
N020066-004NICORETTENICOTINE POLACRILEXEQ 4MG 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
N020066-00283236832028-04-30Drug product2013-01-03

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 06:07:402026-07N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020066-003NICORETTE (MINT)EQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020066-004NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020066-002NICORETTEEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-091e350fbaab3a…

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 06:07:402026-07N020066-00283236832028-04-30Drug product2013-01-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020066-00283236832028-04-30Drug product2013-01-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020066-00283236832028-04-30Drug product2013-01-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020066-00283236832028-04-30Drug product2013-01-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020066-00283236832028-04-30Drug product2013-01-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020066-00283236832028-04-30Drug product2013-01-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020066-00283236832028-04-30Drug product2013-01-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020066-00283236832028-04-30Drug product2013-01-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020066-00283236832028-04-30Drug product2013-01-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020066-00283236832028-04-30Drug product2013-01-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020066-00283236832028-04-30Drug product2013-01-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020066-00283236832028-04-30Drug product2013-01-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020066-00283236832028-04-30Drug product2013-01-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020066-00283236832028-04-30Drug product2013-01-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020066-00283236832028-04-30Drug product2013-01-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020066-00283236832028-04-30Drug product2013-01-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020066-00283236832028-04-30Drug product2013-01-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020066-00283236832028-04-30Drug product2013-01-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020066-00283236832028-04-30Drug product2013-01-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020066-00283236832028-04-30Drug product2013-01-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020066-00283236832028-04-30Drug product2013-01-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020066-00283236832028-04-30Drug product2013-01-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N020066-00283236832028-04-30Drug product2013-01-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020066-00283236832028-04-30Drug product2013-01-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020066-00283236832028-04-30Drug product2013-01-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020066-00283236832028-04-30Drug product2013-01-033f01610625f2…
2019-09-15 20:21 UTC2019-09N020066-00283236832028-04-30Drug product2013-01-03b00525d2431f…
2019-07-19 19:46 UTC2019-07N020066-00283236832028-04-30Drug product2013-01-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020066-00283236832028-04-30Drug product2013-01-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020066-00283236832028-04-30Drug product2013-01-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020066-00283236832028-04-30Drug product2013-01-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020066-00283236832028-04-30Drug product2013-01-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020066-00283236832028-04-30Drug product2013-01-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020066-00283236832028-04-30Drug product2013-01-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020066-00283236832028-04-30Drug product2013-01-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N020066-00283236832028-04-30Drug product2013-01-03053a50430f4f…
2023-01-26 05:58 UTC2023-01N020066-00283236832028-04-30Drug product2013-01-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020066-00283236832028-04-30Drug product2013-01-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020066-00283236832028-04-30Drug product2013-01-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020066-00283236832028-04-30Drug product2013-01-03e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Nicorette
Brand name suffix
Fruit Chill
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M3C89ZY6RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
105071Internal RxNorm lookup
209326Internal RxNorm lookup
311975Internal RxNorm lookup
314119Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0206139-59c6-44c3-963c-8cb5f2d69075Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0242-02NicoretteFruit Chill100 in 1 BLISTER PACKGUM, CHEWING10020
0135-0242-02NicoretteFruit Chill1 in 1 CARTONGUM, CHEWING120
0135-0242-03NicoretteFruit Chill190 in 1 BLISTER PACKGUM, CHEWING19020
0135-0242-03NicoretteFruit Chill1 in 1 CARTONGUM, CHEWING120
0135-0242-05NicoretteFruit Chill160 in 1 BLISTER PACKGUM, CHEWING16020
0135-0242-05NicoretteFruit Chill1 in 1 CARTONGUM, CHEWING120
0135-0242-06NicoretteFruit Chill1 in 1 CARTONGUM, CHEWING120
0135-0242-06NicoretteFruit Chill20 in 1 BLISTER PACKGUM, CHEWING2020
0135-0242-08NicoretteFruit Chill20 in 1 CARTONGUM, CHEWING2020
0135-0242-11NicoretteFruit Chill1 in 1 CARTONGUM, CHEWING120
0135-0242-11NicoretteFruit Chill10 in 1 BLISTER PACKGUM, CHEWING1020
0135-0242-14NicoretteFruit Chill25 in 1 CARTONGUM, CHEWING2520
0135-0242-15NicoretteFruit Chill8 in 1 PACKAGEGUM, CHEWING820
0135-0242-15NicoretteFruit Chill25 in 1 CARTONGUM, CHEWING2520
0135-0242-17NicoretteFruit Chill10 in 1 CARTONGUM, CHEWING1020
0135-0242-17NicoretteFruit Chill2 in 1 PACKAGEGUM, CHEWING220
0135-0242-18NicoretteFruit Chill12 in 1 CARTONGUM, CHEWING1220
0135-0242-18NicoretteFruit Chill10 in 1 BLISTER PACKGUM, CHEWING1020
0135-0242-19NicoretteFruit Chill10 in 1 BLISTER PACKGUM, CHEWING1020
0135-0242-19NicoretteFruit Chill18 in 1 CARTONGUM, CHEWING1820

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0242-02EA - Each0135-0242dca80520-3f9a-4bf5-81f0-4730e6e675d012012-07-24
0135-0242-03EA - Each0135-0242d7f2849f-8d2c-47db-b848-592d9edacbbb12015-10-02
0135-0242-05EA - Each0135-0242f8e01e64-e7d9-47b4-8a2e-1ba0e1ee4cb612014-02-04
0135-0242-06EA - Each0135-0242fe1da435-8288-4132-92a2-1d9eaba5be3d12012-07-24
0135-0242-08EA - Each0135-0242a914f8f3-6d23-46c3-814e-f5bfcd5e63b612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
NICOTINEACTIVE MOIETY6M3C89ZY6RNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ACACIAINACTIVE INGREDIENT5C5403N26ONICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QONICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4NICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ENICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0242NICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]20Current NDC, Legacy NDC, 20 package rows20240731_a0206139-59c6-44c3-963c-8cb5f2d69075.zip

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicorette Fruit Chill nicotine polacrilexNICOTINELil' Drug Store Products, Inc.01db011d-924c-40e4-bd5d-44eb267b8de12024-12-30WarningsExact identifier
application applno (NDA): 020066
application number: NDA020066
Nicorette White Mint nicotine polacrilexNICOTINELil' Drug Store Products, Inc.4aec3330-411e-415f-a505-3ab7fa7295bb2024-12-30WarningsExact identifier
application applno (NDA): 020066
application number: NDA020066
Nicorette OriginalNICOTINE POLACRILEXHaleon US Holdings LLC673fd19f-69b3-4f73-b9b4-18b5f4cbf69c2024-08-13WarningsExact identifier
application applno (NDA): 020066
application number: NDA020066
Nicorette Fruit ChillNICOTINE POLACRILEXHaleon US Holdings LLCa0206139-59c6-44c3-963c-8cb5f2d690752024-07-29WarningsExact identifier
application applno (NDA): 020066
application number: NDA020066
ndc (product): 0135-0242
Nicorette 4mg Fruit Chill Gum, Lil Drug StoreNICOTINE POLACRILEXLil' Drug Store Products, Inc.0e85dcfa-d9e1-5fbb-e063-6394a90aeae62024-01-09WarningsExact identifier
application applno (NDA): 020066
application number: NDA020066
Nicorette 4mg White Ice Mint Gum, Lil Drug StoreNICOTINE POLACRILEXLil' Drug Store Products, Inc.0e894f4f-2d41-24c2-e063-6294a90ae26c2024-01-09WarningsExact identifier
application applno (NDA): 020066
application number: NDA020066
Nicorette 4mg Cinnamon SurgeNICOTINE POLACRILEXLil' Drug Store products, Inc.0e74e9fd-f79a-ffea-e063-6394a90a721e2024-01-08WarningsExact identifier
application applno (NDA): 020066
application number: NDA020066

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209326Nicorette 2 MG Chewing GumPSNa0206139-59c6-44c3-963c-8cb5f2d6907520
105071Nicorette 4 MG Chewing GumPSNa0206139-59c6-44c3-963c-8cb5f2d6907520
314119nicotine polacrilex 2 MG Chewing GumPSNa0206139-59c6-44c3-963c-8cb5f2d6907520
311975nicotine polacrilex 4 MG Chewing GumPSNa0206139-59c6-44c3-963c-8cb5f2d6907520
209326nicotine 2 MG Chewing Gum [Nicorette]SBDa0206139-59c6-44c3-963c-8cb5f2d6907520
105071nicotine 4 MG Chewing Gum [Nicorette]SBDa0206139-59c6-44c3-963c-8cb5f2d6907520
314119nicotine 2 MG Chewing GumSCDa0206139-59c6-44c3-963c-8cb5f2d6907520
311975nicotine 4 MG Chewing GumSCDa0206139-59c6-44c3-963c-8cb5f2d6907520
209326Nicorette 2 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYa0206139-59c6-44c3-963c-8cb5f2d6907520
209326Nicorette 2 MG Chewing GumSYa0206139-59c6-44c3-963c-8cb5f2d6907520
105071Nicorette 4 MG Chewing GumSYa0206139-59c6-44c3-963c-8cb5f2d6907520
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYa0206139-59c6-44c3-963c-8cb5f2d6907520
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYa0206139-59c6-44c3-963c-8cb5f2d6907520

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0242-02001350242021 BLISTER PACK in 1 CARTON (0135-0242-02) / 100 GUM, CHEWING in 1 BLISTER PACK1 blister pack2009-09-140000-00-00NoNoCurrent
0135-0242-0300135024203190 in 1 BLISTER PACKHistorical
0135-0242-05001350242051 BLISTER PACK in 1 CARTON (0135-0242-05) / 160 GUM, CHEWING in 1 BLISTER PACK1 blister pack2009-09-140000-00-00NoNoCurrent
0135-0242-06001350242061 BLISTER PACK in 1 CARTON (0135-0242-06) / 20 GUM, CHEWING in 1 BLISTER PACK1 blister pack2009-09-140000-00-00NoNoCurrent
0135-0242-080013502420820 GUM, CHEWING in 1 CARTON (0135-0242-08) 2009-09-140000-00-00NoNoCurrent
0135-0242-11001350242111 BLISTER PACK in 1 CARTON (0135-0242-11) / 10 GUM, CHEWING in 1 BLISTER PACK1 blister pack2009-09-140000-00-00NoNoCurrent
0135-0242-140013502421425 in 1 CARTONHistorical
0135-0242-15001350242158 in 1 PACKAGEHistorical
0135-0242-17001350242172 CARTON in 1 PACKAGE (0135-0242-17) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK2 carton2014-08-010000-00-00NoNoCurrent
0135-0242-180013502421812 BLISTER PACK in 1 CARTON (0135-0242-18) / 10 GUM, CHEWING in 1 BLISTER PACK12 blister pack2018-09-010000-00-00NoNoCurrent
0135-0242-190013502421918 BLISTER PACK in 1 CARTON (0135-0242-19) / 10 GUM, CHEWING in 1 BLISTER PACK18 blister pack2018-12-030000-00-00NoNoCurrent