Nicotine

Product NDC: 0363-0365
11-digit product format: 003630365
Labeler code: 0363
Product ID: 0363-0365_3f364d1d-07d0-4b85-bda1-bc5edcac2652
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Walgreen Company
Application: ANDA091349
Marketing category: ANDA
Marketing start: 2013-03-22
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	0363-0365		D	Discontinued by firm	2026-08-10
excluded package	package	0363-0365	0363-0365-06	D	Discontinued by firm	2026-08-10
excluded package	package	0363-0365	0363-0365-58	D	Discontinued by firm	2026-08-10
excluded package	package	0363-0365	0363-0365-76	D	Discontinued by firm	2026-08-10
excluded package	package	0363-0365	0363-0365-78	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 · 30 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	0363-0365-76	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0363-0365-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0363-0365-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0363-0365-78	`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	0363-0365-76	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0363-0365-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0363-0365-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0363-0365-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0363-0365-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0363-0365-76	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0363-0365-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0363-0365-76	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0363-0365-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0363-0365-76	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0363-0365-58	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0363-0365-76	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-0365-58	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-0365-76	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-0365-58	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-0365-76	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-0365-58	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-0365-76	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0363-0365-58	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0363-0365-76	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0363-0365-58	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0363-0365-76	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0363-0365-58	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0363-0365-76	`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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0365-06	EA - Each	0363-0365	0dc3a80d-a4ca-4dbc-82e2-ace3d8e64195	1	2013-12-02
0363-0365-78	EA - Each	0363-0365	19d366c2-4491-43ee-a5ba-c9546a933e72	1	2020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0365	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]	9	Legacy NDC	20221020_9adf55d6-330b-4828-bab3-befad8c950ef.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
0363-0365-06	00363036506	160 BLISTER PACK in 1 CARTON (0363-0365-06) > 1 GUM, CHEWING in 1 BLISTER PACK	160 blister pack	2013-06-07	0000-00-00	No	No	Current
0363-0365-76	00363036576	120 BLISTER PACK in 1 CARTON (0363-0365-76) > 1 GUM, CHEWING in 1 BLISTER PACK	120 blister pack	2014-04-10	0000-00-00	No	No	Current
0363-0365-78	00363036578	100 BLISTER PACK in 1 CARTON (0363-0365-78) > 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2013-06-07	0000-00-00	No	No	Current