Rexall Nicotine

Product NDC: 55910-532
11-digit product format: 559100532
Labeler code: 55910
Product ID: 55910-532_2d8aee56-ab8d-4e1a-a568-dd355ae69b5a
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Dolgencorp, LLC
Application: ANDA076779
Marketing category: ANDA
Marketing start: 2011-05-17
Substance: NICOTINE
Active strength: 4 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	55910-532		D	Discontinued by firm		2026-08-03
excluded package	package	55910-532	55910-532-60	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
A076779-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2004-09-16

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	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076779-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
55910-532-60	Rexall Nicotine	20 in 1 CARTON	GUM, CHEWING	20		7
55910-532-60	Rexall Nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-532	REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20210515_d5921224-43c1-4726-ba61-180ea79423b6.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	fa4d83cd-5998-440c-9d20-1d880996994d	2026-06-25	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	fa916f6b-0582-4e2a-bbed-6c47778c5d03	2026-06-19	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Nicotine	NICOTINE POLACRILEX	H E B	c690001d-12c4-4a0f-b9b0-2d2b73dcd93a	2026-06-18	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
dg health nicotine	NICOTINE POLACRILEX	Dolgencorp Inc	64b2982d-491e-42e7-b65e-7abf5530b935	2026-06-11	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	302f4785-77e6-433f-83d9-d0d2618d5ef2	2026-05-20	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Nicotine	NICOTINE POLACRILEX	Walgreen Company	c44821ba-5c2a-4586-8210-afc02a4031d5	2026-05-05	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	dc4d4fe1-6a60-4f02-b04f-a500e22d25da	2026-04-28	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Foster and Thrive Nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	23d8c1a7-a1e4-488d-bc66-b22683abf08b	2026-04-27	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	788214db-3f78-4209-b3b6-d59cc9be3421	2026-02-18	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	b451316e-6c78-4156-ad28-c10166deec79	2026-01-29	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	a1c85adc-8b42-40ad-91b4-0bf92a6341a5	2025-09-16	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779
Up and Up Nicotine	NICOTINE POLACRILEX	Target Corporation	a4bf013b-286b-486c-bb8f-2defb3881d4c	2024-04-21	Warnings	Exact identifier application applno (ANDA): 076779 application number: ANDA076779

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	d5921224-43c1-4726-ba61-180ea79423b6	7
311975	nicotine 4 MG Chewing Gum	SCD	d5921224-43c1-4726-ba61-180ea79423b6	7
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	d5921224-43c1-4726-ba61-180ea79423b6	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-532-60	55910053260	20 BLISTER PACK in 1 CARTON (55910-532-60) / 1 GUM, CHEWING in 1 BLISTER PACK	20 blister pack	2011-05-17	0000-00-00	No	No	Current