UP AND UP COATED CINNAMON NICOTINE

Product NDC
82442-329
11-digit product format
824420329
Labeler code
82442
Product ID
82442-329_c07500a4-5cee-4529-968e-db988e7b4f75
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Target Corporation
Application
ANDA206393
Marketing category
ANDA
Marketing start
2025-01-29
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206393-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-153f01610625f2…
2019-09-15 20:21 UTC2019-09A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206393-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-12-15cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
UP AND UP COATED CINNAMON 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
311975Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
35f4b873-9700-4d7b-9edd-700dae58f500Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82442-329-06UP AND UP COATED CINNAMON NICOTINE1 in 1 BLISTER PACKGUM, CHEWING13
82442-329-06UP AND UP COATED CINNAMON NICOTINE160 in 1 CARTONGUM, CHEWING1603
82442-329-78UP AND UP COATED CINNAMON NICOTINE1 in 1 BLISTER PACKGUM, CHEWING13
82442-329-78UP AND UP COATED CINNAMON NICOTINE100 in 1 CARTONGUM, CHEWING1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82442-329UP AND UP COATED CINNAMON NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]2Current NDC, 4 package rows20250202_35f4b873-9700-4d7b-9edd-700dae58f500.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 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nicotineNICOTINE POLACRILEXPublix Super Markets Inc4ddba70a-3f45-4c76-a12a-6da256e9afc52026-07-23WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLCc6c9582c-004d-4925-b147-add5f28f38562026-07-23WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
NicotineNICOTINE POLACRILEXAmazon.com Services LLCda4c5203-76d7-454f-85bd-1717d95506bd2026-07-20WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companybfdf3918-3116-4351-b0a8-4c515e2e1f412026-07-14WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC03d9708a-923c-4fd3-ac3d-6ab4a4d8a8042026-06-30WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
nicotineNICOTINE POLACRILEXH E B9bf10dfc-c6df-4cc9-ba79-2dcf874a29042026-06-26WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
nicotineNICOTINE POLACRILEXH E B55defc7f-f91d-46eb-8558-2ab1b69ec6a12026-06-26WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC44cce141-dd0e-47ba-b7fe-7cd6f7935ba52026-06-26WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
NicotineNICOTINE POLACRILEXKroger Company1d55fe3e-9c41-409f-8b1d-3c02688903e92026-06-25WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
nicotineNICOTINE POLACRILEXKroger Company37ad9304-7a00-4ec0-bbbb-cf133e0e8bc82026-06-25WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
nicotineNICOTINE POLACRILEXMeijer Distribution Inc860f8306-4cd4-4444-8c6e-182ddeb10ad62026-06-25WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLCbbeb84ae-c98f-422e-9770-e44961af593f2026-06-25WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
nicotineNICOTINEH E Bbfe954a2-c078-4a63-a3bb-f9ef7d8806f72026-06-25WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
NicotineNICOTINE POLACRILEXMeijer Distribution Inc9a1c3e96-9a12-448b-a732-e4eb277327f72026-06-25WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
signature care nicotineNICOTINE POLACRILEXSafewaybcf4407a-b0ff-40bb-9bb9-6c36bdd525fc2026-06-19WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
signature care nicotineNICOTINE POLACRILEXSafeway1a5508fb-14b7-4ede-a238-6e328ae706da2026-06-19WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
careone nicotineNICOTINE POLACRILEXAmerican Sales Companybe90d633-e928-484c-9fa7-d363c23bb89c2026-06-19WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
Berkley and Jensen NicotineNICOTINE POLACRILEXBJWCb04f4f1e-55d3-4486-acf1-6a93dc919f2d2026-06-19WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC107d6b24-fa5e-4fff-8365-b0b92251708e2026-06-18WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393
COATED NICOTINENICOTINE POLACRILEXPublix Super Markets Inc8868a487-d77b-4c6f-8ef9-5a6fe22ce0ad2026-06-18WarningsExact identifier
application applno (ANDA): 206393
application number: ANDA206393

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN35f4b873-9700-4d7b-9edd-700dae58f5003
311975nicotine 4 MG Chewing GumSCD35f4b873-9700-4d7b-9edd-700dae58f5003
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY35f4b873-9700-4d7b-9edd-700dae58f5003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82442-329-0682442032906160 BLISTER PACK in 1 CARTON (82442-329-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2025-01-29NoNoCurrent
82442-329-7882442032978100 BLISTER PACK in 1 CARTON (82442-329-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2025-01-29NoNoCurrent