basic care nicotine

Product NDC
0113-0704
11-digit product format
001130704
Labeler code
0113
Product ID
0113-0704_8e9a1400-cfc9-47ef-9aab-3cbc5982dabc
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA206394
Marketing category
ANDA
Marketing start
2018-01-22
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 productproduct0113-0704DDiscontinued by firm2026-08-03
excluded packagepackage0113-07040113-0704-06DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0113-0704-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0113-0704-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0113-0704-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0113-0704-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0113-0704-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0113-0704-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0113-0704-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0113-0704-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0113-0704-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0113-0704-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0113-0704-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0113-0704-06557ba5c1ecfa…9c80585c8c6e…

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
A206394-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG 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 UTC2026-02A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-153f01610625f2…
2019-09-15 20:21 UTC2019-09A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206394-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2016-12-15cb3db0bc1861…

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 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc2eca67db-1b7c-43dd-91af-4060e9b8e9d32026-07-15WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
Kirkland Signature Quit 2NICOTINE POLACRILEXCostco Wholesale Company17f17eb6-ebc3-4a71-9f1b-41e2b5dcf6c12026-07-14WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
coated nicotineNICOTINE POLACRILEXPublix Super Markets Inc97b06ada-b8b8-49fc-bc65-c3e835ef149b2026-07-13WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
nicotineNICOTINE POLACRILEXPublix Super Markets Inc61c69497-91f9-45bf-ad48-33ac73e63a752026-07-10WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
topcare nicotineNICOTINE POLACRILEXTopco Associates LLCc3c52b83-fdbe-4999-b982-37c63462eb7c2026-06-30WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLCf0f79275-c27a-4d35-a79a-53b0905c37612026-06-29WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
nicotineNICOTINE POLACRILEXH E Ba1f36614-539f-45db-aad4-1b300c60bf432026-06-26WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC060ef0cb-52ef-47b1-bcba-856e443d18a92026-06-26WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
NicotineNICOTINE POLACRILEXKroger Company7295628f-3a9c-4e64-855b-0511aba641752026-06-25WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
HEB NicotineNICOTINE POLACRILEXH E B9e74cde3-4819-4868-b47e-fe6d1362fa592026-06-25WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLC949d429c-3af3-4512-b742-2bfbf4701c342026-06-25WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
NicotineNICOTINE POLACRILEXMeijer Distribution Inc6627f4e3-1c62-43af-be58-df67f7a2dcaa2026-06-25WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
nicotineNICOTINE POLACRILEXKroger Company3621f5df-f036-4d9f-9972-40e47912d7132026-06-25WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
Foster and Thrive NicotineNICOTINE POLACRILEXStrategic Sourcing Services LLCf2d0bf82-3cc7-4b06-9f2d-0c927416f6cf2026-06-24WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
signature care nicotineNICOTINE POLACRILEXSafewaya2c00ec8-3762-4594-a1dd-0b5add001d392026-06-19WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
careone nicotineNICOTINE POLACRILEXAmerican Sales Company21ae0d43-b78d-4f7e-90f1-01479454fc6b2026-06-19WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
Berkley and Jensen NICOTINENICOTINE POLACRILEXBJWCcdaa2643-7630-41e8-bd48-4a760cf4a46a2026-06-19WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
NicotineNICOTINEH E Bda70bf12-4454-40ac-8cfd-8b7697496d552026-06-19WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
signature care nicotineNICOTINE POLACRILEXSafewayda824d13-9dfa-41e5-a6ac-0081f5de74a82026-06-19WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394
nicotineNICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltdf9759891-7d3d-4714-8f8b-92d0a499e52e2026-06-11WarningsExact identifier
application applno (ANDA): 206394
application number: ANDA206394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0704-0600113070406160 BLISTER PACK in 1 CARTON (0113-0704-06) > 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2018-01-220000-00-00NoNoCurrent