nicotine polacrilex

Product NDC
30142-170
Requested package NDC
30142-170-25
11-digit product format
301420170
Labeler code
30142
Product ID
30142-170_ff0b21da-497b-488e-affa-3caf2bd1047e
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Kroger Company
Application
ANDA076789
Marketing category
ANDA
Marketing start
2005-12-15
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 packagepackage30142-17030142-170-25DDiscontinued by firm2026-08-03

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
A076789-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16

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 UTC2026-02A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-163f01610625f2…
2019-09-15 20:21 UTC2019-09A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076789-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16cb3db0bc1861…

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
30142-170-25nicotine polacrilex1 in 1 BLISTER PACKGUM, CHEWING16
30142-170-25nicotine polacrilex110 in 1 CARTONGUM, CHEWING1106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30142-170-25EA - Each30142-1708c25282d-7167-465b-a3c7-817c7c05b1b712016-03-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-170NICOTINE POLACRILEX GUM, CHEWING [KROGER COMPANY]6Current NDC, Legacy NDC, 2 package rows20210406_6b0d030b-5b82-4630-b169-3b434391d3d1.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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nicotineNICOTINE POLACRILEXPublix Super Markets Incecdfe02c-813b-4c1e-9e02-d7c544a896442026-07-23WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companyb9dd4e89-0023-4552-bdd6-1c046ce3bd872026-07-14WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companyae802de5-8e1b-439f-ab81-db4bd7241c912026-07-10WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
signature care nicotineNICOTINE POLACRILEXSafeway3591828f-dff0-4cb7-ab0e-d43704243dc22026-06-12WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
nicotineNICOTINE POLACRILEXH E Bbbc4fd9f-b1f5-4691-b980-3424c91e4c882026-06-12WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
members mark nicotineNICOTINE POLACRILEXSam's West Inc8edad777-6491-4ab2-9835-709bf54d5f0c2026-06-11WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
NicotineNICOTINE POLACRILEXMeijer Distribution Incdc6b806a-f571-4d33-9b93-3dcd21ad02602026-06-09WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC63ac801f-02ed-43a1-a2a8-2ad35d8fd7a92026-06-09WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
nicotineNICOTINE POLACRILEXRite Aid Corporation1c49ddd3-0f2c-4310-acf1-edd42e3aafc52026-04-28WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
up and up uncoated original nicotineNICOTINE POLACRILEXTarget Corporationf837023e-29e1-49c5-89af-b491e8302fd92026-04-18WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
careone nicotineNICOTINE POLACRILEXAmerican Sales Company97926c62-b56a-4ce0-addb-037d90d297e72026-04-03WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
Equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc0eb7bd68-7260-404c-a928-7898c6c265722026-02-23WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC1a916693-6092-4875-872a-7438816c0ddf2026-02-12WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLCd146d768-b975-462c-bc94-c2132e1bdac72023-08-28WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789
berkley and jensen nicotineNICOTINE POLACRILEXBJWCcf91dba6-f461-4370-920b-bc148089afe72021-04-02WarningsExact identifier
application applno (ANDA): 076789
application number: ANDA076789

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN6b0d030b-5b82-4630-b169-3b434391d3d16
311975nicotine 4 MG Chewing GumSCD6b0d030b-5b82-4630-b169-3b434391d3d16
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY6b0d030b-5b82-4630-b169-3b434391d3d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-170-2530142017025110 BLISTER PACK in 1 CARTON (30142-170-25) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2005-12-150000-00-00NoNoCurrent