Application 078968

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	GUM, CHEWING;BUCCAL	EQ 4MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078968-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2008-04-23

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078968-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-04-23	`f41ea6bd6efb…`

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 21 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense nicotine	NICOTINE POLACRILEX	A-S Medication Solutions	3e9a5f94-9db2-4cac-8ab9-50fcedfe0e05	2025-07-16	Warnings	Name fallback generic name: NICOTINE POLACRILEX
stop smoking aid	NICOTINE POLACRILEX	Publix Super Markets Inc	5f205c02-e3a1-4fa1-8cb6-b4da52662c00	2025-07-14	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Mini Nicotine	NICOTINE POLACRILEX	Chain Drug Consortium, LLC	380ce6c2-3e29-4bdf-a600-f6990925a307	2025-06-30	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex, Original	NICOTINE POLACRILEX	Chain Drug Consortium, LLC	cb67cd5e-9264-4530-a678-da299476f356	2025-06-30	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Mini	NICOTINE POLACRILEX	ATLANTIC BIOLOGICALS CORP.	31e0dadd-2678-4e3c-9e62-e3766c21ce5f	2025-06-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Mini Nicotine	NICOTINE POLACRILEX	ATLANTIC BIOLOGICALS CORP.	a0fc3eae-9c34-48af-bdd2-d95e91b68a9c	2025-06-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Rugby Nicotine Polacrilex Gum, Original Flavor	NICOTINE POLACRILEX	ATLANTIC BIOLOGICALS CORP.	57e08517-4c8a-487a-bfbe-2a43f105f4b9	2025-06-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Rugby Nicotine Polacrilex Gum, Mint Flavor	NICOTINE POLACRILEX	ATLANTIC BIOLOGICALS CORP.	62609a8d-bcbe-420c-aed8-edfdf022ff26	2025-06-27	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicorette Cherry Peppermint	NICOTINE POLACRILEX	Haleon US Holdings LLC	35438b53-2760-bcfe-e063-6394a90a65c0	2025-06-09	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICORETTE	NICOTINE POLACRILEX	Haleon US Holdings LLC	f350e050-2173-43e0-8738-848382ce0700	2025-06-04	Warnings	Name fallback generic name: NICOTINE POLACRILEX
members mark nicotine	NICOTINE POLACRILEX	Sam's West Inc	78126814-286e-485f-a4ce-77587f3d77e3	2025-06-04	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Members Mark Nicotine	NICOTINE POLACRILEX	Sam's West Inc	36c15917-eceb-4f5a-9021-711956e7b51b	2025-06-03	Warnings	Name fallback generic name: NICOTINE POLACRILEX
equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	bfa8273c-5af8-4074-b6d4-a99a0d0ff712	2025-05-15	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	AAFES/Your Military Exchanges	27308f6b-43b9-4b1d-af6b-7a39b79def03	2025-05-08	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
AMAZON BASIC CARE NICOTINE POLACRILEX	NICOTINE POLACRILEX	Amazon.com Services LLC	113e0be9-7edc-4766-e063-6294a90af752	2025-05-02	Warnings	Name fallback generic name: NICOTINE POLACRILEX
AMAZON BASIC CARE NICOTINE POLACRILEX	NICOTINE POLACRILEX	Amazon.com Services LLC	10ece1fa-f4c2-42ad-e063-6394a90a3a7d	2025-05-02	Warnings	Name fallback generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Lucy Goods, Inc.	b97d27d2-a6e1-40da-bdc2-eaf7b88321f6	2025-04-29	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
Nicotine Polacrilex	NICOTINE POLACRILEX	Lucy Goods, Inc.	23ca9fd2-41a0-4210-ad97-62ec84d79907	2025-04-28	Warnings	Name fallback brand name: Nicotine Polacrilex generic name: NICOTINE POLACRILEX
NICORETTE	NICOTINE POLACRILEX	Haleon US Holdings LLC	c7f32ab1-f6bd-46f5-9852-8eb5b78a3326	2025-04-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX
NICORETTE	NICOTINE POLACRILEX	Haleon US Holdings LLC	ffeb8286-860d-49f5-8df3-724afb4aaad8	2025-04-25	Warnings	Name fallback generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11673-652	up and up nicotine	Nicotine polacrilex	Target Corporation	ANDA	Current