Nicorette

Product NDC
0135-8070
Requested package NDC
0135-8070-81
11-digit product format
001358070
Labeler code
0135
Product ID
0135-8070_3724f342-04db-e129-e063-6294a90a6c7d
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA022360
Marketing category
NDA
Marketing start
2026-04-01
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022360-001NICORETTENICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18
N022360-002NICORETTENICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022360-00189407722029-04-30Drug product2015-02-25
N022360-00185011642029-06-14Drug product2013-09-05
N022360-00289407722029-04-30Drug product2015-02-25
N022360-00285011642029-06-14Drug product2013-09-05

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18782e0a99824c…
2021-12-28 21:50 UTC2021-12N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022360-00189407722029-04-30Drug product2015-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022360-00185011642029-06-14Drug product2013-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022360-00289407722029-04-30Drug product2015-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022360-00285011642029-06-14Drug product2013-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022360-00189407722029-04-30Drug product2015-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022360-00185011642029-06-14Drug product2013-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022360-00289407722029-04-30Drug product2015-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022360-00285011642029-06-14Drug product2013-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022360-00189407722029-04-30Drug product2015-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022360-00185011642029-06-14Drug product2013-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022360-00289407722029-04-30Drug product2015-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022360-00285011642029-06-14Drug product2013-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022360-00189407722029-04-30Drug product2015-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022360-00185011642029-06-14Drug product2013-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022360-00289407722029-04-30Drug product2015-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022360-00285011642029-06-14Drug product2013-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022360-00189407722029-04-30Drug product2015-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022360-00185011642029-06-14Drug product2013-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022360-00289407722029-04-30Drug product2015-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022360-00285011642029-06-14Drug product2013-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022360-00189407722029-04-30Drug product2015-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022360-00185011642029-06-14Drug product2013-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022360-00289407722029-04-30Drug product2015-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022360-00285011642029-06-14Drug product2013-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022360-00189407722029-04-30Drug product2015-02-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022360-00185011642029-06-14Drug product2013-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022360-00289407722029-04-30Drug product2015-02-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022360-00285011642029-06-14Drug product2013-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022360-00189407722029-04-30Drug product2015-02-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022360-00185011642029-06-14Drug product2013-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022360-00289407722029-04-30Drug product2015-02-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022360-00285011642029-06-14Drug product2013-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022360-00189407722029-04-30Drug product2015-02-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022360-00185011642029-06-14Drug product2013-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022360-00289407722029-04-30Drug product2015-02-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022360-00285011642029-06-14Drug product2013-09-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022360-00189407722029-04-30Drug product2015-02-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N022360-00185011642029-06-14Drug product2013-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N022360-00289407722029-04-30Drug product2015-02-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N022360-00285011642029-06-14Drug product2013-09-05d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Nicorette
Brand name suffix
Cherry Peppermint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 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
359817Internal RxNorm lookup
359818Internal RxNorm lookup
968849Internal RxNorm lookup
968851Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
35438b53-2760-bcfe-e063-6394a90a65c0Available 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-8070-20NicoretteCherry Peppermint20 in 1 VIALLOZENGE202
0135-8070-20NicoretteCherry Peppermint1 in 1 PACKAGELOZENGE12
0135-8070-81NicoretteCherry Peppermint27 in 1 VIALLOZENGE272
0135-8070-81NicoretteCherry Peppermint3 in 1 PACKAGELOZENGE32

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicorette PeppermintNICOTINE POLACRILEXHaleon US Holdings LLC990a4a65-d573-46a9-889d-60afb00189442025-07-31WarningsExact identifier
application applno (NDA): 022360
application number: NDA022360
Nicorette Cherry PeppermintNICOTINE POLACRILEXHaleon US Holdings LLC35438b53-2760-bcfe-e063-6394a90a65c02025-06-09WarningsExact identifier
application applno (NDA): 022360
application number: NDA022360
ndc (package): 0135-8070-81
ndc (product): 0135-8070
ndc11 (package): 00135807081
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCc7f32ab1-f6bd-46f5-9852-8eb5b78a33262025-04-25WarningsExact identifier
application applno (NDA): 022360
application number: NDA022360
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCfdee1637-8049-4bc5-b196-b6d854c9f9f32024-03-05WarningsExact identifier
application applno (NDA): 022360
application number: NDA022360

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968849Nicorette 2 MG Oral LozengePSN35438b53-2760-bcfe-e063-6394a90a65c02
968851Nicorette 4 MG Oral LozengePSN35438b53-2760-bcfe-e063-6394a90a65c02
359817nicotine 2 MG Oral LozengePSN35438b53-2760-bcfe-e063-6394a90a65c02
359818nicotine 4 MG Oral LozengePSN35438b53-2760-bcfe-e063-6394a90a65c02
968849nicotine 2 MG Oral Lozenge [Nicorette]SBD35438b53-2760-bcfe-e063-6394a90a65c02
968851nicotine 4 MG Oral Lozenge [Nicorette]SBD35438b53-2760-bcfe-e063-6394a90a65c02
359817nicotine 2 MG Oral LozengeSCD35438b53-2760-bcfe-e063-6394a90a65c02
359818nicotine 4 MG Oral LozengeSCD35438b53-2760-bcfe-e063-6394a90a65c02
968849Nicorette 2 MG (nicotine polacrilex 11.1 MG) Oral LozengeSY35438b53-2760-bcfe-e063-6394a90a65c02
968849Nicorette 2 MG Oral LozengeSY35438b53-2760-bcfe-e063-6394a90a65c02
968849Nicorette 2 MG TrocheSY35438b53-2760-bcfe-e063-6394a90a65c02
968851Nicorette 4 MG (nicotine polacrilex 22.2 MG) Oral LozengeSY35438b53-2760-bcfe-e063-6394a90a65c02
968851Nicorette 4 MG Oral LozengeSY35438b53-2760-bcfe-e063-6394a90a65c02
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY35438b53-2760-bcfe-e063-6394a90a65c02
359817nicotine 2 MG TrocheSY35438b53-2760-bcfe-e063-6394a90a65c02
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY35438b53-2760-bcfe-e063-6394a90a65c02
359818nicotine 4 MG TrocheSY35438b53-2760-bcfe-e063-6394a90a65c02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-8070-81001358070813 VIAL in 1 PACKAGE (0135-8070-81) / 27 LOZENGE in 1 VIAL3 vial2026-04-01NoNoCurrent