Nicotine Polacrilex

Product NDC: 55319-966
11-digit product format: 553190966
Labeler code: 55319
Product ID: 55319-966_f4825c27-4253-4314-aa55-4d9819030f30
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Family Dollar (FAMILY WELLNESS)
Application: ANDA204833
Marketing category: ANDA
Marketing start: 2023-07-01
Marketing end: 2028-03-28
Substance: NICOTINE
Active strength: 4 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204833-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-02-26	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Nicotine Polacrilex

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
d353b75f-3fc3-4958-92c6-08df6bdf283c	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55319-966-20	Nicotine Polacrilex	1 in 1 BLISTER PACK	GUM, CHEWING	1		7
55319-966-20	Nicotine Polacrilex	20 in 1 CARTON	GUM, CHEWING	20		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-966	NICOTINE POLACRILEX GUM, CHEWING [FAMILY DOLLAR (FAMILY WELLNESS)]	4	Current NDC, 2 package rows	20240829_d353b75f-3fc3-4958-92c6-08df6bdf283c.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 ndc (product): 55319-966
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311975	nicotine polacrilex 4 MG Chewing Gum	PSN	d353b75f-3fc3-4958-92c6-08df6bdf283c	7
311975	nicotine 4 MG Chewing Gum	SCD	d353b75f-3fc3-4958-92c6-08df6bdf283c	7
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	d353b75f-3fc3-4958-92c6-08df6bdf283c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-966-20	55319096620	20 BLISTER PACK in 1 CARTON (55319-966-20) / 1 GUM, CHEWING in 1 BLISTER PACK	20 blister pack	2023-07-01	2028-03-28	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotine 4 mg Ice Mint Coated USP Gum	Family Dollar (FAMILY WELLNESS)	2026-03-18	HUMAN OTC DRUG LABEL	7