Nicotine

Product NDC: 63868-842
11-digit product format: 638680842
Labeler code: 63868
Product ID: 63868-842_495451a3-9c2e-4d19-9cf8-337042f87498
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: ANDA079038
Marketing category: ANDA
Marketing start: 2020-04-27
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63868-842		D	Discontinued by firm		2026-08-03
excluded package	package	63868-842	63868-842-20	D	Discontinued by firm		2026-08-03

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
A079038-001	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	A079038-001	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	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079038-001	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	A079038-001	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	A079038-001	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	A079038-001	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	A079038-001	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	A079038-001	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	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079038-001	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	A079038-001	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	A079038-001	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	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079038-001	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	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079038-001	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	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079038-001	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	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079038-001	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	A079038-001	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	A079038-001	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	A079038-001	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	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079038-001	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	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079038-001	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	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-842-20	EA - Each	63868-842	cd995827-f4dc-41b6-b6d5-7ddef0984327	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-842	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	4	Legacy NDC	20231018_16bbdc36-92e1-405d-8b14-b73d1ee53587.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	P & L Development, LLC	fbb3f6af-529f-40d8-a193-1aed4f2aa769	2026-06-22	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine Polacrilex coated fruit	NICOTINE POLACRILEX	CVS Pharmacy	8c5e99d7-9d2d-488b-a804-496edafd30cf	2026-05-05	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine Polacrilex Coated Fruit	NICOTINE POLACRILEX	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	d6c7a2ab-109d-40df-bce0-30c3531eb982	2026-04-10	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine	NICOTINE POLACRILEX	Walgreens	dda17eef-cd75-4c82-b468-09111298282d	2026-03-25	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine	NICOTINE POLACRILEX	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	11e537db-7dc7-4b28-97eb-da70c80d8fe3	2026-03-19	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor	NICOTINE POLACRILEX	Rugby Laboratories	b973d045-7791-49c1-9216-4e0d51173735	2026-02-27	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine Polacrilex Coated Fruit	NICOTINE POLACRILEX	Publix Supermarkets, Inc.	c161e2d6-7691-4fd0-9f91-acfc33685420	2026-02-23	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine Polacrilex	NICOTINE POLACRILEX	AAFES/Your Military Exchanges	6d895db2-7423-42bc-ae78-e0b47189e2d2	2026-01-16	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruit	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	5d3b45d6-97c2-4400-ad09-95a4b21f5324	2025-12-23	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine	NICOTINE POLACRILEX	Lucy Goods, Inc.	20aa42c6-14e3-46c5-ba0f-fef217e0b1c2	2025-07-29	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038

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
63868-842-20	63868084220	20 BLISTER PACK in 1 CARTON (63868-842-20) > 1 GUM, CHEWING in 1 BLISTER PACK	20 blister pack	2020-04-27	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	QUALITY CHOICE (Chain Drug Marketing Association)	2023-10-17	HUMAN OTC DRUG LABEL	4