Nicotine Polacrilex

Product NDC: 49035-512
11-digit product format: 490350512
Labeler code: 49035
Product ID: 49035-512_43c699c4-a278-4ac7-a705-18ea03c16248
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: BUCCAL
Labeler: EQUATE (Wal-Mart Stores, Inc.)
Application: ANDA204794
Marketing category: ANDA
Marketing start: 2016-10-01
Marketing end: 2024-07-26
Substance: NICOTINE
Active strength: 2 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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	49035-512		D	Discontinued by firm		2026-08-03
excluded package	package	49035-512	49035-512-44	D	Discontinued by firm		2026-08-03

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 · 22 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	49035-512-44	`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	49035-512-44	`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	49035-512-44	`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	49035-512-44	`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	49035-512-44	`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	49035-512-44	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49035-512-44	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49035-512-44	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49035-512-44	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49035-512-44	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49035-512-44	`367a005e9d99…`	`383a685ebd0f…`

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
A204794-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2016-05-10

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	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Polacrilex Coated Ice Mint	NICOTINE POLACRILEX	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	b075c3cb-d610-4a9c-8cf0-e4b9001bc86a	2026-04-13	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794
Nicotine Polacrilex	NICOTINE POLACRILEX	Chain Drug Consortium, LLC	9c115cd5-1952-4f1e-8e88-27f2c528e91f	2026-03-26	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794
Nicotine Polacrilex coated ice mint	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	c21147f5-da96-424c-9058-24eb751b64ea	2026-03-17	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794
Nicotine Polacrilex	NICOTINE POLACRILEX	Walgreens	b3e33137-bf40-4801-b01f-27a0d41edba4	2026-02-10	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794
Nicotine Polacrilex coated ice mint	NICOTINE POLACRILEX	CVS Pharmacy	e4e3fd5f-1ed1-4a18-9c31-7224cae77ded	2024-10-03	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794

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
49035-512-44	49035051244	100 BLISTER PACK in 1 CARTON (49035-512-44) > 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2016-10-01	2024-07-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotine Polacrilex Coated Ice Mint 2 mg - Walmart	EQUATE (Wal-Mart Stores, Inc.)	2021-10-20	HUMAN OTC DRUG LABEL	3