Application 020066

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002NICORETTENICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 4MG BASEYesYes
003NICORETTE (MINT)NICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 4MG BASEYesNo
004NICORETTENICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 4MG BASEYesNo

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…

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
ndc (product): 29485-5270
Nicorette White Mint nicotine polacrilexNICOTINELil' Drug Store Products, Inc.4aec3330-411e-415f-a505-3ab7fa7295bb2024-12-30WarningsExact identifier
application applno (NDA): 020066
application number: NDA020066
ndc (product): 29485-5271
Nicorette OriginalNICOTINE POLACRILEXHaleon US Holdings LLC673fd19f-69b3-4f73-b9b4-18b5f4cbf69c2024-08-13WarningsExact identifier
application applno (NDA): 020066
application number: NDA020066
ndc (product): 0135-0533
ndc (product): 0135-0467
ndc (product): 0135-0158
ndc (product): 0135-0475
ndc (product): 0135-0355
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
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0135-0158Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0158Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0226Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0226Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0230Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0230Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0242Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0242Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0355Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0355Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0467Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0467Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0475Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0475Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0533Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0135-0533Nicorettenicotine polacrilexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
29485-5270Nicorette Fruit Chill nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5270Nicorette Fruit Chill nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5270Nicorette Fruit Chill nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5270Nicorette Fruit Chill nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5271Nicorette White Mint nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5271Nicorette White Mint nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5271Nicorette White Mint nicotine polacrilexNicotineMechanical Servants LLCNDACurrent
29485-5271Nicorette White Mint nicotine polacrilexNicotineMechanical Servants LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77185SUPPL 2024-01-04
77180SUPPL 2024-01-04
67477SUPPL2021-05-13
67184SUPPL2021-04-27
60977SUPPL2019-11-20
60976SUPPL2019-11-20
56484SUPPL2018-11-23
56534SUPPL2018-11-21
54651SUPPL2018-06-21
54549SUPPL2018-06-14
50746SUPPL2017-12-18
50745SUPPL2017-12-18
49989SUPPL2017-10-10
34228SUPPL2015-11-02
1974SUPPL2015-10-02
34227SUPPL2014-11-07
1973SUPPL2014-11-03
34226SUPPL2014-08-05
12171SUPPL2014-08-05
21099SUPPL2014-06-12
1972SUPPL2014-06-12
12169SUPPL2014-01-16
12170SUPPL2013-11-07
1971SUPPL2013-10-31
21098SUPPL2012-07-18
12168SUPPL2012-03-28
20467SUPPL2012-03-27
21097SUPPL2012-02-17
21096SUPPL2012-02-03
21095SUPPL2011-09-29
21094SUPPL2011-05-19
1970SUPPL2009-05-08
1969SUPPL2008-06-16
21093SUPPL2007-07-05
34225SUPPL2007-06-27
20466SUPPL2007-04-11
21092SUPPL2006-05-05
34224SUPPL2005-12-13
1968SUPPL2005-12-13
21090SUPPL2004-06-24
21091SUPPL2004-06-23
1967SUPPL2004-04-29
1966SUPPL2002-08-09
20465SUPPL2000-09-25
12167SUPPL2000-09-25
1965SUPPL2000-09-25
34223SUPPL1998-12-23
20464SUPPL1998-12-23
21089SUPPL1998-12-13