Nicorette

Product NDC
0135-0230
11-digit product format
001350230
Labeler code
0135
Product ID
0135-0230_1f929250-cbfa-d6eb-e063-6394a90a7281
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
2009-06-29
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0135-02300135-0230-04DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
Mint
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
673fd19f-69b3-4f73-b9b4-18b5f4cbf69cAvailable 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0230-032024-01-30C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0230-042024-01-30C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0230-052024-01-30C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0230-03NicoretteMint1 in 1 CARTONGUM, CHEWING127
0135-0230-03NicoretteMint50 in 1 BLISTER PACKGUM, CHEWING5027
0135-0230-04NicoretteMint1 in 1 CARTONGUM, CHEWING127
0135-0230-04NicoretteMint110 in 1 BLISTER PACKGUM, CHEWING11027
0135-0230-05NicoretteMint170 in 1 BLISTER PACKGUM, CHEWING17027
0135-0230-05NicoretteMint1 in 1 CARTONGUM, CHEWING127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0230-04EA - Each0135-0230f0c40849-63f2-440c-9641-9d431ccf70db12013-03-03
0135-0230-05EA - Each0135-02303fde9132-56a6-4852-bdbd-f0c967f5eedd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
NICOTINEACTIVE MOIETY6M3C89ZY6RNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
ACACIAINACTIVE INGREDIENT5C5403N26ONICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
LEVOMENTHOLINACTIVE INGREDIENTBZ1R15MTK7NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QONICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
SORBITOLINACTIVE INGREDIENT506T60A25RNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
SPEARMINTINACTIVE INGREDIENTJ7I2T6IV1NNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ENICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0230NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 6 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.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
ndc (product): 0135-0230
Nicorette Fruit ChillNICOTINE POLACRILEXHaleon US Holdings LLCa0206139-59c6-44c3-963c-8cb5f2d690752024-07-29WarningsExact identifier
application applno (NDA): 020066
application number: NDA020066
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 GumPSN673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
105071Nicorette 4 MG Chewing GumPSN673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
314119nicotine polacrilex 2 MG Chewing GumPSN673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
311975nicotine polacrilex 4 MG Chewing GumPSN673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
209326nicotine 2 MG Chewing Gum [Nicorette]SBD673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
105071nicotine 4 MG Chewing Gum [Nicorette]SBD673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
314119nicotine 2 MG Chewing GumSCD673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
311975nicotine 4 MG Chewing GumSCD673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
209326Nicorette 2 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
209326Nicorette 2 MG Chewing GumSY673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
105071Nicorette 4 MG Chewing GumSY673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0230-03001350230031 BLISTER PACK in 1 CARTON (0135-0230-03) / 50 GUM, CHEWING in 1 BLISTER PACK1 blister pack2009-06-290000-00-00NoNoCurrent
0135-0230-04001350230041 in 1 CARTONHistorical
0135-0230-05001350230051 BLISTER PACK in 1 CARTON (0135-0230-05) / 170 GUM, CHEWING in 1 BLISTER PACK1 blister pack2009-06-290000-00-00NoNoCurrent