CareOne Mini Nicotine Polacrilex

Product NDC
41520-957
11-digit product format
415200957
Labeler code
41520
Product ID
41520-957_2f975f2a-9842-47a6-9fa7-03241c550644
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
American Sales Company
Application
ANDA203690
Marketing category
ANDA
Marketing start
2013-06-22
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 packagepackage41520-95741520-957-03DDiscontinued 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
CareOne Mini Nicotine Polacrilex
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359818Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d3591f0c-f638-485a-ab34-f71fce6a966fAvailable 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
41520-957-02CareOne Mini Nicotine Polacrilex27 in 1 CONTAINERLOZENGE275
41520-957-02CareOne Mini Nicotine Polacrilex3 in 1 CARTONLOZENGE35
41520-957-03CareOne Mini Nicotine Polacrilex4 in 1 CARTONLOZENGE45
41520-957-03CareOne Mini Nicotine Polacrilex27 in 1 CONTAINERLOZENGE275

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RCAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
NICOTINEACTIVE MOIETY6M3C89ZY6RCAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9CAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
CALCIUM POLYCARBOPHILINACTIVE INGREDIENT8F049NKY49CAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
POLACRILININACTIVE INGREDIENTRCZ785HI7SCAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNCAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQCAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TCAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-957CAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]5Current NDC, Legacy NDC, 4 package rows20231026_d3591f0c-f638-485a-ab34-f71fce6a966f.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
ndc (product): 41520-957
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
359818nicotine 4 MG Oral LozengePSNd3591f0c-f638-485a-ab34-f71fce6a966f5
359818nicotine 4 MG Oral LozengeSCDd3591f0c-f638-485a-ab34-f71fce6a966f5
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYd3591f0c-f638-485a-ab34-f71fce6a966f5
359818nicotine 4 MG TrocheSYd3591f0c-f638-485a-ab34-f71fce6a966f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-957-02415200957023 CONTAINER in 1 CARTON (41520-957-02) / 27 LOZENGE in 1 CONTAINER3 container2013-08-070000-00-00NoNoCurrent
41520-957-03415200957034 CONTAINER in 1 CARTON (41520-957-03) > 27 LOZENGE in 1 CONTAINER4 container2013-06-220000-00-00NoNoCurrent