Nicotine Polacrilex

Product NDC: 57237-323
11-digit product format: 572370323
Labeler code: 57237
Product ID: 57237-323_9230a5f3-bfa3-4a70-8e91-8df2736d9a29
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA078697
Marketing category: ANDA
Marketing start: 2023-08-10
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

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
A078697-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2008-12-29

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	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`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
Listing expiration: 2026-12-31

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
e86b9c22-7ee0-4bd0-adfd-a7b087b1dd71	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	SPL version
57237-323-01	Nicotine Polacrilex	1 in 1 BLISTER PACK	GUM, CHEWING	1	3
57237-323-01	Nicotine Polacrilex	100 in 1 CARTON	GUM, CHEWING	100	3
57237-323-11	Nicotine Polacrilex	110 in 1 CARTON	GUM, CHEWING	110	3
57237-323-11	Nicotine Polacrilex	1 in 1 BLISTER PACK	GUM, CHEWING	1	3
57237-323-50	Nicotine Polacrilex	50 in 1 CARTON	GUM, CHEWING	50	3
57237-323-50	Nicotine Polacrilex	1 in 1 BLISTER PACK	GUM, CHEWING	1	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-323-01	EA - Each	57237-323	6fd67b91-0297-4e50-937a-1d9ea6b78ecf	1	2023-10-16
57237-323-11	EA - Each	57237-323	0609fca6-8393-407b-acd4-82a4836cfb86	1	2026-01-08
57237-323-50	EA - Each	57237-323	7362cc03-6092-464d-be12-3991db207658	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-323	NICOTINE POLACRILEX GUM, CHEWING [RISING PHARMA HOLDINGS, INC.]	2	Current NDC, 6 package rows	20240906_e86b9c22-7ee0-4bd0-adfd-a7b087b1dd71.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	Rugby Laboratories	621eb214-0716-4306-829f-6185a77f24d5	2026-07-16	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex coated mint	NICOTINE POLACRILEX	CVS Pharmacy	84daeb67-5982-4b9e-b56a-4cc6a223a3f8	2026-05-05	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex Coated Mint	NICOTINE POLACRILEX	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	2c420ee4-0ed0-4a3f-bc92-202d825d0ca3	2026-04-13	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex Coated Mint	NICOTINE POLACRILEX	Chain Drug Consortium, LLC	b4ac0a22-3556-4591-aa7b-e09c6010adc8	2026-03-26	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Walgreens	826f63b2-fd18-4213-be38-a430d78897cb	2026-03-25	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	53c82cf8-d97b-4a5a-a357-fb74a74d1ef3	2026-03-18	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex Coated Mint	NICOTINE POLACRILEX	Publix Supermarkets, Inc.	a6ef9fd0-9706-4924-b7f5-e2562b9d99e0	2026-02-23	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	ed5722d7-746b-468e-89b5-506055d12bbd	2025-12-23	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Rising Pharma Holdings, Inc.	e86b9c22-7ee0-4bd0-adfd-a7b087b1dd71	2025-12-06	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697 ndc (product): 57237-323
Nicotine Polacrilex	NICOTINE POLACRILEX	AAFES/Your Military Exchanges	27308f6b-43b9-4b1d-af6b-7a39b79def03	2025-05-08	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Lucy Goods, Inc.	b97d27d2-a6e1-40da-bdc2-eaf7b88321f6	2025-04-29	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4af800f9-bcb3-4320-8d32-f1bfd54ee5e9	2025-04-03	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Quitine LLC	dc142c50-5310-43f5-a9e5-e174116685f8	2024-12-17	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5b30fa5a-fff7-46ec-9f33-fda633cc315d	2024-11-06	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697

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	e86b9c22-7ee0-4bd0-adfd-a7b087b1dd71	3
311975	nicotine 4 MG Chewing Gum	SCD	e86b9c22-7ee0-4bd0-adfd-a7b087b1dd71	3
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	e86b9c22-7ee0-4bd0-adfd-a7b087b1dd71	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
57237-323-01	57237032301	100 BLISTER PACK in 1 CARTON (57237-323-01) / 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2023-08-10	No	No	Current
57237-323-11	57237032311	110 BLISTER PACK in 1 CARTON (57237-323-11) / 1 GUM, CHEWING in 1 BLISTER PACK	110 blister pack	2025-12-08	No	No	Current
57237-323-50	57237032350	50 BLISTER PACK in 1 CARTON (57237-323-50) / 1 GUM, CHEWING in 1 BLISTER PACK	50 blister pack	2025-12-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotine Polacrilex Gum USP, Coated Mint Flavor 4 mg	Rising Pharma Holdings, Inc.	2025-12-06	HUMAN OTC DRUG LABEL	3