Good Sense Nicotine

Product NDC
0113-0734
11-digit product format
001130734
Labeler code
0113
Product ID
0113-0734_d653d9ea-04f7-46eb-a74a-ee8a5e0d3ba0
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA203690
Marketing category
ANDA
Marketing start
2013-04-22
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 packagepackage0113-07340113-0734-03DDiscontinued by firm2026-10-12

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 43.

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
A203690-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09
A203690-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-0984e616aacf4f…
2026-09-14 22:38:342026-08A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-0984e616aacf4f…
2026-08-18 06:07:402026-07A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09caaa826d4ba7…
2026-08-18 06:07:402026-07A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203690-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2012-10-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203690-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2012-10-0974a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense 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
477689fc-688a-4c76-8c02-35a7a15adc5eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
0113-0734-01Good Sense Nicotine27 in 1 CONTAINERLOZENGE277
0113-0734-02Good Sense Nicotine3 in 1 CARTONLOZENGE37
0113-0734-03Good Sense Nicotine27 in 1 CONTAINERLOZENGE277
0113-0734-03Good Sense Nicotine4 in 1 CARTONLOZENGE47
0113-0734-04Good Sense Nicotine5 in 1 CARTONLOZENGE57
0113-0734-07Good Sense Nicotine8 in 1 CARTONLOZENGE87
0113-0734-60Good Sense Nicotine20 in 1 CONTAINERLOZENGE207
0113-0734-60Good Sense Nicotine1 in 1 CARTONLOZENGE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0734-02EA - Each0113-0734a61a3094-4524-4522-ba7d-9027cfb4313b12017-12-14
0113-0734-60EA - Each0113-0734980ddbf2-f0b6-4e63-b400-73877b9bee2c12023-01-09

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0734GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]6Current NDC, Legacy NDC, 8 package rows20240702_477689fc-688a-4c76-8c02-35a7a15adc5e.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 4 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
members mark NicotineNICOTINE POLACRILEXSam's West Incc31c30b9-7431-4b90-b011-f34e499df1922025-11-15WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
nicotine miniNICOTINE POLACRILEXWalgreen Company33e456bb-1d5d-4b06-8f06-8bb4eab5b1fd2025-10-02WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
members mark nicotineNICOTINE POLACRILEXSam's West Incd185b5e7-9bb1-4d16-b146-1fbfba8740532025-09-16WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC7b1b5f6e-c5ee-48fc-85ee-2e11c30213e42025-09-16WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
nicotineNICOTINE POLACRILEXKroger Company0b1874bd-f908-485a-b045-7d0050be7bb22025-09-13WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLC03b27d95-f2cb-43d4-9bc3-55ea66fadb0d2025-09-13WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
mini nicotineNICOTINE POLACRILEXMeijer Distribution Inc426b2f92-561d-476b-959c-cdd0fa37be562025-09-12WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc04f2b325-2243-4c6f-880c-45f2543091da2025-09-12WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepackc2627853-945b-42d8-8351-39028e513d772025-07-29WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepack16ece78d-c66e-43c1-953a-f774797ae0972025-07-29WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepack094de23b-d433-487d-8364-6f245c8117c62025-04-03WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepack3997dda6-89ea-49df-abda-ab420327a4732025-04-03WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
nicotine miniNICOTINE POLACRILEXWalgreen Company4a08b910-5479-49f5-abbe-ca68949efb242024-08-22WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
CareOne Mini Nicotine PolacrilexNICOTINE POLACRILEXAmerican Sales Companyd3591f0c-f638-485a-ab34-f71fce6a966f2023-10-25WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
nicotineNICOTINE POLACRILEXWalgreen Company8af06c23-80b7-4559-b594-a3a02297306d2023-05-28WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc8c66eb21-dd95-4dcb-8488-e1e768dd8cd62022-12-06WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
Rexall NicotineNICOTINE POLACRILEXDolgencorp, LLC83b053f6-304b-4f9c-8a6d-6649998708b22021-12-15WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
NicotineNICOTINE POLACRILEXMeijer Distribution Incdc70703e-2c55-4178-a5d5-50f762ab64922019-04-24WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
NicotineNICOTINE POLACRILEXMeijer Distribution Inc1d2cfb36-2d94-468c-8da1-6b6999b07d7b2019-04-18WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690
signature care nicotineNICOTINE POLACRILEXSafeway22010ed8-7fa6-402a-a314-523538183a552018-11-01WarningsExact identifier
application applno (ANDA): 203690
application number: ANDA203690

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN477689fc-688a-4c76-8c02-35a7a15adc5e7
359817nicotine 2 MG Oral LozengeSCD477689fc-688a-4c76-8c02-35a7a15adc5e7
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY477689fc-688a-4c76-8c02-35a7a15adc5e7
359817nicotine 2 MG TrocheSY477689fc-688a-4c76-8c02-35a7a15adc5e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0734-010011307340127 in 1 CONTAINERHistorical
0113-0734-02001130734023 CONTAINER in 1 CARTON (0113-0734-02) / 27 LOZENGE in 1 CONTAINER (0113-0734-01) 3 container2013-04-220000-00-00NoNoCurrent
0113-0734-03001130734034 CONTAINER in 1 CARTON (0113-0734-03) > 27 LOZENGE in 1 CONTAINER4 container2013-04-220000-00-00NoNoCurrent
0113-0734-04001130734045 CONTAINER in 1 CARTON (0113-0734-04) / 27 LOZENGE in 1 CONTAINER (0113-0734-01) 5 container2024-06-21NoNoCurrent
0113-0734-07001130734078 CONTAINER in 1 CARTON (0113-0734-07) / 27 LOZENGE in 1 CONTAINER (0113-0734-01) 8 container2024-06-21NoNoCurrent
0113-0734-60001130734601 CONTAINER in 1 CARTON (0113-0734-60) / 20 LOZENGE in 1 CONTAINER1 container2018-03-260000-00-00NoNoCurrent