nicotine

Product NDC
41250-344
11-digit product format
412500344
Labeler code
41250
Product ID
41250-344_49f6155b-23e3-430a-a898-ccb0d4ebbeb9
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA077007
Marketing category
ANDA
Marketing start
2006-03-01
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41250-34441250-344-05DDiscontinued by firm2026-08-03
excluded packagepackage41250-34441250-344-06DDiscontinued by firm2026-08-03

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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0541250-344-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0541250-344-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2641250-344-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2641250-344-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3141250-344-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2841250-344-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2141250-344-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1041250-344-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3141250-344-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2041250-344-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1041250-344-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0841250-344-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0341250-344-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0941250-344-06557ba5c1ecfa…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
A077007-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31
A077007-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31

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 UTC2026-02A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077007-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2006-01-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A077007-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2006-01-31782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
nicotine
Listing expiration
2027-12-31

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
7be33f47-03de-458d-81b9-5a8d94052075Available 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
41250-344-03nicotine24 in 1 CONTAINERLOZENGE2410
41250-344-03nicotine1 in 1 CARTONLOZENGE110
41250-344-05nicotine3 in 1 CARTONLOZENGE310
41250-344-05nicotine24 in 1 CONTAINERLOZENGE2410
41250-344-06nicotine4 in 1 CARTONLOZENGE410
41250-344-06nicotine24 in 1 CONTAINERLOZENGE2410
41250-344-10nicotine27 in 1 CONTAINERLOZENGE2710
41250-344-10nicotine4 in 1 CARTONLOZENGE410
41250-344-11nicotine7 in 1 CARTONLOZENGE710
41250-344-11nicotine24 in 1 CONTAINERLOZENGE2410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41250-344-11EA - Each41250-34439b48895-ed95-4e2d-910a-9a6e104c15d512024-04-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-344NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]9Current NDC, Legacy NDC, 10 package rows20250406_7be33f47-03de-458d-81b9-5a8d94052075.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 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nicotineNICOTINE POLACRILEXPublix Super Markets Inc00b40bb3-3785-4a53-804e-633795e87f712026-07-20WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
EQUATE NICOTINENICOTINE POLACRILEXWALMART INC.b6379f86-1528-465d-9527-bd2fead0068f2026-07-15WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company5c89061b-1452-4962-9f25-212f2ae8e41e2026-07-13WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inca0113a1d-3691-4f18-9950-ae6d8d7d19ea2026-07-10WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ef9e55d-83e0-4ba5-a905-8cddb0db00192026-07-09WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inc8cb5577b-48c0-47f8-8979-0ab54d7130452026-07-09WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NicotineNICOTINE POLACRILEXKroger Company35f45900-af2e-4b74-9772-8beb552364572026-06-26WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NicotineNICOTINE POLACRILEXKroger Company0ef57432-471d-4c7a-b8be-0f898f01d1972026-06-26WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
berkley and jensen nicotineNICOTINE POLACRILEXBJWC3a408d89-974f-4a20-aee9-fb1fe0a7ef3e2026-06-25WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NICOTINENICOTINE POLACRILEXPublix Super Markets Incd043920e-d795-4eff-aadd-4c81b01503ea2026-06-22WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NICOTINENICOTINE POLACRILEXH E B9c0122e4-7b5b-40c6-a981-1f7853bf3ce72026-06-18WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NicotineNICOTINE POLACRILEXRite Aid Corporation8b24aefd-1881-4126-9188-29896a17a06d2026-06-03WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NicotineNICOTINE POLACRILEXHyVee Inc7e391e5d-a715-42ae-8c4d-0a7d1a8599892026-06-03WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
nicotineNICOTINE POLACRILEXCVS Pharmacy4bc94e0b-189f-47b0-826c-2ccf6c4a0e3a2026-06-01WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NicotineNICOTINE POLACRILEXRite Aid Corporation9e411b49-c8c4-43f8-a402-5ca2d96db1312026-05-27WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company0ac7f87a-63f4-4d74-ba5b-d1444803b1002026-05-11WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NicotineNICOTINE POLACRILEXWalgreen Company77688e56-4293-4f37-9f48-fe09267ff6192026-05-07WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc53387dd6-28c0-412d-bc74-4d323c8d5e112026-04-16WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
NICOTINENICOTINE POLACRILEXHyVee Inc6415ebf4-5b6f-4811-997d-27c76893bc042026-03-19WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007
nicotine lozengeNICOTINE POLACRILEXH E Bdb78d030-7abf-494f-94ca-4a385f519faf2026-02-27WarningsExact identifier
application applno (ANDA): 077007
application number: ANDA077007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN7be33f47-03de-458d-81b9-5a8d9405207510
359817nicotine 2 MG Oral LozengeSCD7be33f47-03de-458d-81b9-5a8d9405207510
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY7be33f47-03de-458d-81b9-5a8d9405207510
359817nicotine 2 MG TrocheSY7be33f47-03de-458d-81b9-5a8d9405207510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-344-03412500344031 CONTAINER in 1 CARTON (41250-344-03) / 24 LOZENGE in 1 CONTAINER1 container2014-06-200000-00-00NoNoCurrent
41250-344-05412500344053 CONTAINER in 1 CARTON (41250-344-05) > 24 LOZENGE in 1 CONTAINER3 container2009-10-230000-00-00NoNoCurrent
41250-344-06412500344064 in 1 CARTONHistorical
41250-344-10412500344104 CONTAINER in 1 CARTON (41250-344-10) / 27 LOZENGE in 1 CONTAINER4 container2010-03-310000-00-00NoNoCurrent
41250-344-11412500344117 CONTAINER in 1 CARTON (41250-344-11) / 24 LOZENGE in 1 CONTAINER7 container2010-04-160000-00-00NoNoCurrent