Nicotine

Product NDC: 11822-0854
Requested package NDC: 11822-0854-2
11-digit product format: 118220854
Labeler code: 11822
Product ID: 11822-0854_1d0e7562-06c6-4623-825f-423e06d6e7aa
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Rite Aid Corporation
Application: ANDA078546
Marketing category: ANDA
Marketing start: 2007-12-21
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 4 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	11822-0854	11822-0854-2	D	Discontinued by firm		2026-08-10

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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A078546-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2007-05-24

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	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-0854	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	8	Legacy NDC	20250331_8837575b-6179-4f92-881b-f19120445ef7.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	b8cbb6a7-aeb4-48f3-a0ed-7ad803021752	2026-06-26	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	59ba5cba-be1e-4708-a9ab-01f43543bb5b	2026-06-19	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
Care One Nicotine	NICOTINE POLACRILEX	American Sales Company	78cf8b14-cdad-464c-afb5-9fc49ebc3921	2026-06-19	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	426e7bbc-cf58-4be0-a8e5-30a8f7ca5b48	2026-05-20	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	0f1b3cc6-98df-4e34-91f3-dc251fe170f8	2026-04-28	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
Equate Nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	54c1a1d5-f7b4-4109-8887-02dc10bfd593	2025-09-16	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6M3C89ZY6R	NICOTINE	54-11-5	NICOTINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-0854-2	11822085402	120 BLISTER PACK in 1 CARTON (11822-0854-2) > 1 GUM, CHEWING in 1 BLISTER PACK	120 blister pack	2016-10-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rite Aid Corporation Nicotine Gum Drug Facts	Rite Aid Corporation	2025-03-26	HUMAN OTC DRUG LABEL	8