Nicotine

Product NDC
0363-0873
11-digit product format
003630873
Labeler code
0363
Product ID
0363-0873_bdd5bb7b-8a44-48ac-acee-c9cb5ef3cb13
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA077007
Marketing category
ANDA
Marketing start
2006-02-23
Substance
NICOTINE
Active strength
4 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-08730363-0873-06DDiscontinued 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 · 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
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
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
77688e56-4293-4f37-9f48-fe09267ff619Available 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
0363-0873-03Nicotine24 in 1 CONTAINERLOZENGE2411
0363-0873-05Nicotine3 in 1 CARTONLOZENGE311
0363-0873-06Nicotine4 in 1 CARTONLOZENGE411
0363-0873-09Nicotine27 in 1 CONTAINERLOZENGE2711
0363-0873-10Nicotine4 in 1 CARTONLOZENGE411
0363-0873-16Nicotine6 in 1 CARTONLOZENGE611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0873-05EA - Each0363-087396309fee-14f5-4201-a852-8649b6a3480712014-10-03
0363-0873-06EA - Each0363-08733b1b075d-f17c-49ca-8d7d-36a5af905d8912015-02-02
0363-0873-10EA - Each0363-08739fe2efe2-48fc-4483-aa3d-f8d8376e90bb12014-10-03
0363-0873-16EA - Each0363-0873a0d55d51-a95e-4ff8-bbf6-e3bdeae8be3c12022-06-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0873NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREEN COMPANY]10Current NDC, Legacy NDC, 6 package rows20250322_77688e56-4293-4f37-9f48-fe09267ff619.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
ndc (product): 0363-0873
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
359818nicotine 4 MG Oral LozengePSN77688e56-4293-4f37-9f48-fe09267ff61911
359818nicotine 4 MG Oral LozengeSCD77688e56-4293-4f37-9f48-fe09267ff61911
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY77688e56-4293-4f37-9f48-fe09267ff61911
359818nicotine 4 MG TrocheSY77688e56-4293-4f37-9f48-fe09267ff61911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0873-030036308730324 in 1 CONTAINERHistorical
0363-0873-05003630873053 CONTAINER in 1 CARTON (0363-0873-05) / 24 LOZENGE in 1 CONTAINER (0363-0873-03) 3 container2010-06-220000-00-00NoNoCurrent
0363-0873-06003630873064 CONTAINER in 1 CARTON (0363-0873-06) > 24 LOZENGE in 1 CONTAINER4 container2015-08-130000-00-00NoNoCurrent
0363-0873-090036308730927 in 1 CONTAINERHistorical
0363-0873-10003630873104 CONTAINER in 1 CARTON (0363-0873-10) / 27 LOZENGE in 1 CONTAINER (0363-0873-09) 4 container2013-02-220000-00-00NoNoCurrent
0363-0873-16003630873166 CONTAINER in 1 CARTON (0363-0873-16) / 24 LOZENGE in 1 CONTAINER (0363-0873-03) 6 container2015-10-010000-00-00NoNoCurrent