nicotine gum

Product NDC: 11822-0365
11-digit product format: 118220365
Labeler code: 11822
Product ID: 11822-0365_3d2fec60-48a6-494f-a663-35a85661a1c1
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Rite Aid Corporation
Application: ANDA091349
Marketing category: ANDA
Marketing start: 2016-07-30
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 2 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	11822-0365		D	Discontinued by firm	2026-08-10
excluded package	package	11822-0365	11822-0365-1	D	Discontinued by firm	2026-08-10
excluded package	package	11822-0365	11822-0365-2	D	Discontinued by firm	2026-08-10
excluded package	package	11822-0365	11822-0365-3	D	Discontinued by firm	2026-08-10
excluded package	package	11822-0365	11822-0365-4	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 · 27 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	11822-0365-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11822-0365-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11822-0365-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11822-0365-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11822-0365-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11822-0365-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11822-0365-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11822-0365-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11822-0365-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11822-0365-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11822-0365-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11822-0365-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11822-0365-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11822-0365-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11822-0365-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11822-0365-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11822-0365-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11822-0365-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11822-0365-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11822-0365-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11822-0365-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11822-0365-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11822-0365-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11822-0365-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11822-0365-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11822-0365-2	`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
A091349-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2011-07-20

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	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091349-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-0365	NICOTINE GUM (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]	7	Legacy NDC	20231207_3872c622-1a30-459c-b878-61648bb30627.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	83532228-931b-43ab-8a3d-0c2a74d4e010	2026-03-15	Warnings	Exact identifier application applno (ANDA): 091349 application number: ANDA091349

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
11822-0365-1	11822036501	100 BLISTER PACK in 1 CARTON (11822-0365-1) > 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2016-07-30	0000-00-00	No	No	Current
11822-0365-2	11822036502	120 BLISTER PACK in 1 CARTON (11822-0365-2) > 1 GUM, CHEWING in 1 BLISTER PACK	120 blister pack	2016-10-12	0000-00-00	No	No	Current
11822-0365-3	11822036503	10 BLISTER PACK in 1 CARTON (11822-0365-3) > 1 GUM, CHEWING in 1 BLISTER PACK	10 blister pack	2017-10-25	0000-00-00	No	No	Current
11822-0365-4	11822036504	20 BLISTER PACK in 1 CARTON (11822-0365-4) > 1 GUM, CHEWING in 1 BLISTER PACK	20 blister pack	2020-06-17	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	2023-11-09	HUMAN OTC DRUG LABEL	7