Nicotine Polacrilex

Product NDC: 11822-3314
11-digit product format: 118223314
Labeler code: 11822
Product ID: 11822-3314_a0018572-c6b4-449d-8079-e55ac8384a46
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Rite Aid Corporation
Application: ANDA204833
Marketing category: ANDA
Marketing start: 2019-12-27
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 4 mg/1
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	11822-3314		D	Discontinued by firm	2026-08-03
excluded product	product	11822-3314		D	Discontinued by firm	2026-08-03
excluded package	package	11822-3314	11822-3314-8	D	Discontinued by firm	2026-08-03
excluded package	package	11822-3314	11822-3314-0	D	Discontinued by firm	2026-08-03
excluded package	package	11822-3314	11822-3314-2	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 · 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	11822-3314-8	`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	11822-3314-8	`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	11822-3314-8	`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	11822-3314-8	`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	11822-3314-8	`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	11822-3314-8	`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	11822-3314-8	`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	11822-3314-8	`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	11822-3314-8	`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	11822-3314-8	`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	11822-3314-8	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11822-3314-8	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11822-3314-8	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11822-3314-8	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11822-3314-8	`1332a3947898…`	`d4bfe170f9cd…`

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
A204833-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2016-02-26

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	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11822-3314-8	2026-01-02	C162847	48780-1	1030e365-0da8-111a-e063-dadaa90a10e2	Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - Equate
11822-3314-8	2024-01-30	C162847	48780-1	1030e365-0da8-111a-e063-dadaa90a10e2	Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - Equate

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-3314	NICOTINE POLACRILEX GUM, CHEWING [RITE AID CORPORATION]	5	Legacy NDC	20231102_cf0ca52f-2de7-4377-a164-1d86d462819a.zip
11822-3314	NICOTINE POLACRILEX GUM, CHEWING [RITE AID CORPORATION]	2	Legacy NDC	20220114_d970580a-e36b-4bde-ac17-081611f606b3.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 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): 204833 application number: ANDA204833
Nicotine Polacrilex	NICOTINE POLACRILEX	Chain Drug Consortium, LLC	9c115cd5-1952-4f1e-8e88-27f2c528e91f	2026-03-26	Warnings	Exact identifier application applno (ANDA): 204833 application number: ANDA204833
Nicotine Polacrilex	NICOTINE POLACRILEX	Family Dollar (FAMILY WELLNESS)	d353b75f-3fc3-4958-92c6-08df6bdf283c	2026-03-18	Warnings	Exact identifier application applno (ANDA): 204833 application number: ANDA204833
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): 204833 application number: ANDA204833
Nicotine Polacrilex	NICOTINE POLACRILEX	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ee883114-35ac-4b81-b8f1-4903d646dd84	2026-02-11	Warnings	Exact identifier application applno (ANDA): 204833 application number: ANDA204833
Nicotine Polacrilex	NICOTINE POLACRILEX	Walgreens	5741531a-3886-4b0a-ae92-d7c238488fdf	2026-02-04	Warnings	Exact identifier application applno (ANDA): 204833 application number: ANDA204833
Nicotine Polacrilex coated ice mint	NICOTINE POLACRILEX	CVS Pharmacy	e4e3fd5f-1ed1-4a18-9c31-7224cae77ded	2024-10-03	Warnings	Exact identifier application applno (ANDA): 204833 application number: ANDA204833

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
11822-3314-0	11822331400	100 BLISTER PACK in 1 CARTON (11822-3314-0) > 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2020-01-31	0000-00-00	No	No	Current
11822-3314-2	11822331402	160 BLISTER PACK in 1 CARTON (11822-3314-2) > 1 GUM, CHEWING in 1 BLISTER PACK	160 blister pack	2020-01-31	0000-00-00	No	No	Current
11822-3314-8	11822331408	20 BLISTER PACK in 1 CARTON (11822-3314-8) > 1 GUM, CHEWING in 1 BLISTER PACK	20 blister pack	2019-12-27	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	Rite Aid Corporation	2026-01-02	HUMAN OTC DRUG LABEL	7
Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - Equate	Rite Aid Corporation	2026-01-02	HUMAN OTC DRUG LABEL	3