Leader Nicotine

Product NDC: 37205-968
11-digit product format: 372050968
Labeler code: 37205
Product ID: 37205-968_3e3bb63d-0818-4d75-aff0-ee12f99b806d
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Cardinal Health
Application: ANDA076779
Marketing category: ANDA
Marketing start: 2007-01-04
Marketing end: 2019-04-01
Substance: NICOTINE
Active strength: 4 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	37205-968		D	Discontinued by firm	2026-08-03
excluded package	package	37205-968	37205-968-58	D	Discontinued by firm	2026-08-03
excluded package	package	37205-968	37205-968-78	D	Discontinued by firm	2026-08-03

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37205-968-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37205-968-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37205-968-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37205-968-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37205-968-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37205-968-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37205-968-78	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37205-968-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37205-968-78	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37205-968-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37205-968-78	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37205-968-58	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37205-968-78	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37205-968-58	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37205-968-78	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37205-968-58	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37205-968-78	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37205-968-58	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37205-968-78	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37205-968-58	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37205-968-78	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37205-968-58	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37205-968-78	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37205-968-58	`557ba5c1ecfa…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076779-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2004-09-16

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-968-58	EA - Each	37205-968	db0b1cf3-af0f-4807-a692-e2e2629694a8	1	2012-07-24
37205-968-78	EA - Each	37205-968	3d9817ae-7108-403a-b3a6-7ae12c98e48e	1	2012-07-24

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	fa4d83cd-5998-440c-9d20-1d880996994d	2026-06-25	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	fa916f6b-0582-4e2a-bbed-6c47778c5d03	2026-06-19	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Nicotine	NICOTINE POLACRILEX	H E B	c690001d-12c4-4a0f-b9b0-2d2b73dcd93a	2026-06-18	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
dg health nicotine	NICOTINE POLACRILEX	Dolgencorp Inc	64b2982d-491e-42e7-b65e-7abf5530b935	2026-06-11	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	302f4785-77e6-433f-83d9-d0d2618d5ef2	2026-05-20	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Nicotine	NICOTINE POLACRILEX	Walgreen Company	c44821ba-5c2a-4586-8210-afc02a4031d5	2026-05-05	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	dc4d4fe1-6a60-4f02-b04f-a500e22d25da	2026-04-28	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Foster and Thrive Nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	23d8c1a7-a1e4-488d-bc66-b22683abf08b	2026-04-27	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	788214db-3f78-4209-b3b6-d59cc9be3421	2026-02-18	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	b451316e-6c78-4156-ad28-c10166deec79	2026-01-29	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	a1c85adc-8b42-40ad-91b4-0bf92a6341a5	2025-09-16	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Up and Up Nicotine	NICOTINE POLACRILEX	Target Corporation	a4bf013b-286b-486c-bb8f-2defb3881d4c	2024-04-21	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779