Nicotine

Product NDC
59779-397
Requested package NDC
59779-397-05
11-digit product format
597790397
Labeler code
59779
Product ID
59779-397_f8fcf4fe-2c57-4c18-a799-c5ba8bc0c998
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA090711
Marketing category
ANDA
Marketing start
1998-06-23
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

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 packagepackage59779-39759779-397-05DDiscontinued by firm2026-08-07

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 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
A090711-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10
A090711-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10

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 UTC2026-02A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090711-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2009-07-10782e0a99824c…
2021-12-28 21:50 UTC2021-12A090711-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2009-07-10782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359817Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-397-03Nicotine1 in 1 CARTONLOZENGE110
59779-397-03Nicotine24 in 1 CONTAINERLOZENGE2410
59779-397-05Nicotine24 in 1 CONTAINERLOZENGE2410
59779-397-05Nicotine3 in 1 CARTONLOZENGE310
59779-397-06Nicotine4 in 1 CARTONLOZENGE410
59779-397-06Nicotine24 in 1 CONTAINERLOZENGE2410
59779-397-09Nicotine27 in 1 CONTAINERLOZENGE2710
59779-397-10Nicotine4 in 1 CARTONLOZENGE410
59779-397-11Nicotine24 in 1 CONTAINERLOZENGE2410
59779-397-11Nicotine7 in 1 CARTONLOZENGE710

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-397NICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]10Current NDC, Legacy NDC, 10 package rows20240711_5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b2.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICOTINENICOTINE POLACRILEXAmazon.com Services LLCec341a77-5b62-4980-8d31-27c12ae925612026-07-28WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXPublix Super Markets Inca9402b4b-f8e6-4e96-ad45-5875dfd0c8892026-07-10WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXPublix Super Markets Inc8c296647-00a1-43d0-acd1-7c1e92f368832026-07-09WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
NicotineNICOTINE POLACRILEXKroger Companye4a7cf2a-5fd9-4390-8517-e532900ff81c2026-06-26WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXRite Aid Corporationf1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c2026-05-27WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companydd334b2c-bbae-48e7-8f3d-2706d325f6002026-05-26WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXRite Aid Corporation6020abb5-2a4f-4602-8014-e2b4e462c05f2026-05-15WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXMeijer Distribution Inc18ee7d8b-7b18-404e-8e62-c10355bb0a262026-04-25WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXMeijer Distribution Inc3566423d-3ddb-4913-9da5-fb43680f0efc2026-04-08WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
NicotineNICOTINE POLACRILEXWalgreen Company74f306d4-2a71-48c9-ab98-378260507a9d2026-03-01WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC99da90fa-00ff-4c62-91a2-1e434dadaf412026-02-12WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
topcare nicotine polacrilexNICOTINE POLACRILEXTopco Associates LLCd0403746-f866-42da-ad66-2a686c8bce012026-02-11WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
NicotineNICOTINE POLACRILEXKroger Company69a61101-df32-444e-a49a-eccfeebfb20e2025-12-11WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC5d23992f-a010-4604-b64c-94ab6b134e6d2025-12-04WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
Quitine nicotineNICOTINE POLACRILEXQUITINE LLC90232b4e-cbf4-4d03-973a-41f4ebb4e5de2025-12-04WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLC47561b44-572e-4ca0-b91c-db07061313632025-08-25WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
nicotineNICOTINE POLACRILEXWalgreen Company4a81d378-009d-43a9-a895-e371ffa700e92025-03-19WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
NicotineNICOTINE POLACRILEXCVS Pharmacy5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b22024-07-08WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
ndc (package): 59779-397-05
ndc (product): 59779-397
ndc11 (package): 59779039705
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED114418c4-6f39-46ce-912c-ac3687b7b75e2024-07-03WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711
up and up cherry nicotineNICOTINE POLACRILEXTarget Corporation85d82812-9f90-401f-8a2c-729cbfdf4c782024-03-29WarningsExact identifier
application applno (ANDA): 090711
application number: ANDA090711

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b210
359817nicotine 2 MG Oral LozengeSCD5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b210
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b210
359817nicotine 2 MG TrocheSY5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-397-05597790397053 CONTAINER in 1 CARTON (59779-397-05) > 24 LOZENGE in 1 CONTAINER3 container2009-10-010000-00-00NoNoCurrent