Nicotine Polacrilex

Product NDC: 55301-504
11-digit product format: 553010504
Labeler code: 55301
Product ID: 55301-504_f9506509-28e9-490f-88db-7ca4823ca731
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: BUCCAL
Labeler: AAFES/Your Military Exchanges
Application: ANDA079038
Marketing category: ANDA
Marketing start: 2014-01-01
Substance: NICOTINE
Active strength: 4 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A079038-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2009-07-08

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	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079038-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2009-07-08	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nicotine Polacrilex
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311975	Internal RxNorm lookup
314119	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
6d895db2-7423-42bc-ae78-e0b47189e2d2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
55301-504-44	Nicotine Polacrilex	1 in 1 BLISTER PACK	GUM, CHEWING	1		16
55301-504-44	Nicotine Polacrilex	100 in 1 CARTON	GUM, CHEWING	100		16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55301-504	NICOTINE POLACRILEX GUM, CHEWING [AAFES/YOUR MILITARY EXCHANGES]	15	Current NDC, Legacy NDC, 2 package rows	20250510_6d895db2-7423-42bc-ae78-e0b47189e2d2.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	P & L Development, LLC	fbb3f6af-529f-40d8-a193-1aed4f2aa769	2026-06-22	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine Polacrilex coated fruit	NICOTINE POLACRILEX	CVS Pharmacy	8c5e99d7-9d2d-488b-a804-496edafd30cf	2026-05-05	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine Polacrilex Coated Fruit	NICOTINE POLACRILEX	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	d6c7a2ab-109d-40df-bce0-30c3531eb982	2026-04-10	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine	NICOTINE POLACRILEX	Walgreens	dda17eef-cd75-4c82-b468-09111298282d	2026-03-25	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine	NICOTINE POLACRILEX	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	11e537db-7dc7-4b28-97eb-da70c80d8fe3	2026-03-19	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor	NICOTINE POLACRILEX	Rugby Laboratories	b973d045-7791-49c1-9216-4e0d51173735	2026-02-27	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine Polacrilex Coated Fruit	NICOTINE POLACRILEX	Publix Supermarkets, Inc.	c161e2d6-7691-4fd0-9f91-acfc33685420	2026-02-23	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine Polacrilex	NICOTINE POLACRILEX	AAFES/Your Military Exchanges	6d895db2-7423-42bc-ae78-e0b47189e2d2	2026-01-16	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038 ndc (product): 55301-504
Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruit	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	5d3b45d6-97c2-4400-ad09-95a4b21f5324	2025-12-23	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038
Nicotine	NICOTINE POLACRILEX	Lucy Goods, Inc.	20aa42c6-14e3-46c5-ba0f-fef217e0b1c2	2025-07-29	Warnings	Exact identifier application applno (ANDA): 079038 application number: ANDA079038

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
314119	nicotine polacrilex 2 MG Chewing Gum	PSN	6d895db2-7423-42bc-ae78-e0b47189e2d2	16
311975	nicotine polacrilex 4 MG Chewing Gum	PSN	6d895db2-7423-42bc-ae78-e0b47189e2d2	16
314119	nicotine 2 MG Chewing Gum	SCD	6d895db2-7423-42bc-ae78-e0b47189e2d2	16
311975	nicotine 4 MG Chewing Gum	SCD	6d895db2-7423-42bc-ae78-e0b47189e2d2	16
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	6d895db2-7423-42bc-ae78-e0b47189e2d2	16
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	6d895db2-7423-42bc-ae78-e0b47189e2d2	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55301-504-44	55301050444	100 BLISTER PACK in 1 CARTON (55301-504-44) / 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2014-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotine Polacrilex Gum Coated Fruit 2mg and 4 mg	AAFES/Your Military Exchanges	2026-01-16	HUMAN OTC DRUG LABEL	16