Nicotac Nicotine Polacrilex

Product NDC
66715-9804
Requested package NDC
66715-9804-4
11-digit product format
667159804
Labeler code
66715
Product ID
66715-9804_d35f391d-62db-da44-e053-2995a90ab429
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
Lil' Drug Store Products, Inc.
Application
ANDA079216
Marketing category
ANDA
Marketing start
2018-04-03
Marketing end
2024-04-02
Substance
NICOTINE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage66715-980466715-9804-4DDiscontinued 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079216-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08

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 UTC2026-02A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-083f01610625f2…
2019-09-15 20:21 UTC2019-09A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079216-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2009-07-08cb3db0bc1861…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine Polacrilex coated cinnamonNICOTINE POLACRILEXCVS Pharmacyd9da6bd9-f655-446d-98b8-5b22db80dad22026-05-12WarningsExact identifier
application applno (ANDA): 079216
application number: ANDA079216
NicotineNICOTINE POLACRILEXH E B526bc299-657a-4899-aa72-04e151a38cba2026-04-02WarningsExact identifier
application applno (ANDA): 079216
application number: ANDA079216
Nicotine PolacrilexNICOTINE POLACRILEXRugby Laboratoriesd67149d5-4766-4b84-8205-f1a6b692f4c92026-02-26WarningsExact identifier
application applno (ANDA): 079216
application number: ANDA079216
Nicotine PolacrilexNICOTINE POLACRILEXWalgreensb1174e20-e1ad-4c58-8b32-683b7e98fca92026-02-10WarningsExact identifier
application applno (ANDA): 079216
application number: ANDA079216
Habitrol Nicotine Polacrilex 2 mg Coated CinnamonNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.6874a9f1-d180-4073-8226-df6e21bcf0b72025-12-23WarningsExact identifier
application applno (ANDA): 079216
application number: ANDA079216
Nicotine PolacrilexNICOTINE POLACRILEXRite Aid Corporation63a433aa-8c73-47a0-be64-8708f8478fff2025-08-07WarningsExact identifier
application applno (ANDA): 079216
application number: ANDA079216
Nicotine PolacrilexNICOTINE POLACRILEXLucy Goods, Inc.76034dd1-361c-442c-92aa-8fa7cf47a5072025-07-18WarningsExact identifier
application applno (ANDA): 079216
application number: ANDA079216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9804-46671598040410 BLISTER PACK in 1 CARTON (66715-9804-4) > 1 GUM, CHEWING in 1 BLISTER PACK10 blister pack2018-10-152024-04-02NoNoCurrent