Nicotine

Product NDC: 63868-849
11-digit product format: 638680849
Labeler code: 63868
Product ID: 63868-849_9658713e-6c70-48e3-ac13-9a2904ede155
Type: HUMAN OTC DRUG
Nonproprietary name: nicotine polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: ANDA074507
Marketing category: ANDA
Marketing start: 2021-01-29
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 2 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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	63868-849		D	Discontinued by firm		2026-08-17
excluded package	package	63868-849	63868-849-11	D	Discontinued by firm		2026-08-17

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, 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	63868-849-11	`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	63868-849-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63868-849-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63868-849-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63868-849-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63868-849-11	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A074507-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			1999-03-15

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-849-11	2023-05-08	C162847	48780-1	f386c649-b522-0266-e053-dadaa90a7c1a	Drug Facts
63868-849-11	2023-01-30	C162847	48780-1	f386c649-b522-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-849-11	EA - Each	63868-849	50bc025d-7274-45ba-8647-7c1be983bff8	1	2022-11-07

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	Rugby Laboratories	1fc88637-4329-486e-82ab-19eeb06080a6	2026-07-15	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine	NICOTINE POLACRILEX	P & L Development, LLC	c65c1c40-4c8f-40bb-ace4-8bbc9ecf630e	2026-06-16	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine Polacrilex original	NICOTINE POLACRILEX	Walgreens	f759d9b2-35e0-4b88-9219-4c0e483af5c4	2026-05-19	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine Polacrilex original	NICOTINE POLACRILEX	CVS Pharmacy	62231539-ae9f-4665-ba59-bef047e93d8a	2026-05-08	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine Polacrilex Original	NICOTINE POLACRILEX	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	4acbda22-9c87-49f2-ad5f-55b1e54bdf2e	2026-04-10	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine	NICOTINE POLACRILEX	Walgreens	69ffbb37-e26c-4214-8d09-0bbabed25310	2026-03-20	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	be693c28-58d5-42ed-ab86-2a28af931051	2026-03-17	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine	NICOTINE POLACRILEX	McKesson Corporation dba SKY Packaging	9ac37719-24c2-4ec7-9fb3-6408d8a5fc7a	2026-01-09	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine Polacrilex, Original	NICOTINE POLACRILEX	Chain Drug Consortium, LLC	cb67cd5e-9264-4530-a678-da299476f356	2025-06-30	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine	NICOTINE POLACRILEX	The Kroger Co.	8c81c885-1d56-4dca-b9bc-adfc9bf58051	2025-02-25	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine Polacrilex Original Flavor	NICOTINE POLACRILEX	Publix Supermarkets, Inc.	540c88bd-70dc-416a-8d8e-0a33b2b29563	2024-07-30	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507

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
63868-849-11	63868084911	110 BLISTER PACK in 1 CARTON (63868-849-11) > 1 GUM, CHEWING in 1 BLISTER PACK	110 blister pack	2021-01-29	0000-00-00	No	No	Current