Nicotine

Product NDC: 0363-3911
11-digit product format: 003633911
Labeler code: 0363
Product ID: 0363-3911_c6eab86c-99d8-424c-b4a2-6be56cf6d603
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Walgreens
Application: ANDA079219
Marketing category: ANDA
Marketing start: 2020-10-30
Substance: NICOTINE
Active strength: 4 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A079219-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2009-07-08

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	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079219-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nicotine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6M3C89ZY6R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311975	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d933d32c-cb4a-41b2-9563-da74cf2d77e4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-3911-10	Nicotine	100 in 1 CARTON	GUM, CHEWING	100	5
0363-3911-10	Nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1	5
0363-3911-16	Nicotine	160 in 1 CARTON	GUM, CHEWING	160	5
0363-3911-16	Nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-3911	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREENS]	5	Current NDC, Legacy NDC, 4 package rows	20221007_d933d32c-cb4a-41b2-9563-da74cf2d77e4.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Polacrilex coated cinnamon	NICOTINE POLACRILEX	CVS Pharmacy	d9da6bd9-f655-446d-98b8-5b22db80dad2	2026-05-12	Warnings	Exact identifier application applno (ANDA): 079219 application number: ANDA079219
Nicotine	NICOTINE POLACRILEX	H E B	056ca637-d5b9-4790-a5a4-c9b58f93e88b	2026-04-02	Warnings	Exact identifier application applno (ANDA): 079219 application number: ANDA079219
Nicotine Polacrilex	NICOTINE POLACRILEX	Rugby Laboratories	d67149d5-4766-4b84-8205-f1a6b692f4c9	2026-02-26	Warnings	Exact identifier application applno (ANDA): 079219 application number: ANDA079219
Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	5c394758-1179-455a-a562-c8e954fb2258	2025-12-23	Warnings	Exact identifier application applno (ANDA): 079219 application number: ANDA079219
Nicotine	NICOTINE POLACRILEX	Lucy Goods, Inc.	bca1c2ab-2263-429d-9f09-f848dd3d826e	2025-07-21	Warnings	Exact identifier application applno (ANDA): 079219 application number: ANDA079219
Nicotine	NICOTINE POLACRILEX	McKesson Corporation dba SKY Packaging	0b6880c8-04e7-418a-98d1-0c7d19e025b3	2025-03-06	Warnings	Exact identifier application applno (ANDA): 079219 application number: ANDA079219
Nicotine	NICOTINE POLACRILEX	Walgreens	d933d32c-cb4a-41b2-9563-da74cf2d77e4	2022-10-06	Warnings	Exact identifier application applno (ANDA): 079219 application number: ANDA079219 ndc (product): 0363-3911

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311975	nicotine polacrilex 4 MG Chewing Gum	PSN	d933d32c-cb4a-41b2-9563-da74cf2d77e4	5
311975	nicotine 4 MG Chewing Gum	SCD	d933d32c-cb4a-41b2-9563-da74cf2d77e4	5
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	d933d32c-cb4a-41b2-9563-da74cf2d77e4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-3911-10	00363391110	100 BLISTER PACK in 1 CARTON (0363-3911-10) / 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2020-10-30	0000-00-00	No	No	Current
0363-3911-16	00363391116	160 BLISTER PACK in 1 CARTON (0363-3911-16) / 1 GUM, CHEWING in 1 BLISTER PACK	160 blister pack	2020-10-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - Equate	Walgreens	2022-10-06	HUMAN OTC DRUG LABEL	5