Nicotine Polacrilex

Product NDC: 72484-428
Requested package NDC: 72484-428-16
11-digit product format: 724840428
Labeler code: 72484
Product ID: 72484-428_956fb87b-f80a-6372-e053-2a95a90ac9ae
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: BUCCAL
Labeler: Roman Health Ventures Inc.
Application: ANDA078699
Marketing category: ANDA
Marketing start: 2018-10-08
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 2 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72484-428	72484-428-16	I	Inactivated by FDA		2026-08-11

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A078699-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG 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 · 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	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078699-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`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
72484-428-16	2023-01-30	C162847	48780-1	f386c64a-3532-0266-e053-dadaa90a7c1a	Nicotine Polarilex Coated Mint 2 mg and 4 mg - Roman

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72484-428-16	Nicotine Polacrilexcoated mint	160 in 1 CARTON	GUM, CHEWING	160		2
72484-428-16	Nicotine Polacrilexcoated mint	1 in 1 BLISTER PACK	GUM, CHEWING	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72484-428	NICOTINE POLACRILEX COATED MINT (NICOTINE POLACRILEX) GUM, CHEWING [ROMAN HEALTH VENTURES INC.]	2	Legacy NDC, 2 package rows	20191024_d60f90a5-10ea-442b-9ec5-2f2a69ec6441.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
Nicotine	NICOTINE POLACRILEX	Rugby Laboratories	621eb214-0716-4306-829f-6185a77f24d5	2026-07-16	Warnings	Exact identifier application applno (ANDA): 078699 application number: ANDA078699
Nicotine Polacrilex coated mint	NICOTINE POLACRILEX	CVS Pharmacy	84daeb67-5982-4b9e-b56a-4cc6a223a3f8	2026-05-05	Warnings	Exact identifier application applno (ANDA): 078699 application number: ANDA078699
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): 078699 application number: ANDA078699
Nicotine Polacrilex Coated Mint	NICOTINE POLACRILEX	Chain Drug Consortium, LLC	b4ac0a22-3556-4591-aa7b-e09c6010adc8	2026-03-26	Warnings	Exact identifier application applno (ANDA): 078699 application number: ANDA078699
Nicotine Polacrilex	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	7b789f4c-7786-4b32-9460-69de57e0a3aa	2026-03-17	Warnings	Exact identifier application applno (ANDA): 078699 application number: ANDA078699
Nicotine Polacrilex	NICOTINE POLACRILEX	Walgreens	fe5c4bfd-a792-4923-b2db-16be44d599ea	2026-03-12	Warnings	Exact identifier application applno (ANDA): 078699 application number: ANDA078699
Nicotine Polacrilex Coated Mint	NICOTINE POLACRILEX	Publix Supermarkets, Inc.	a6ef9fd0-9706-4924-b7f5-e2562b9d99e0	2026-02-23	Warnings	Exact identifier application applno (ANDA): 078699 application number: ANDA078699
Habitrol Nicotine Polacrilex Gum 2 mg Coated Mint	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	826f0ce5-9862-4f6f-8943-a3f06b07e69f	2025-12-22	Warnings	Exact identifier application applno (ANDA): 078699 application number: ANDA078699
Nicotine Polacrilex	NICOTINE POLACRILEX	Rising Pharma Holdings, Inc.	a3f19365-d0d1-43ad-be15-48dc4320e361	2025-12-06	Warnings	Exact identifier application applno (ANDA): 078699 application number: ANDA078699
Nicotine Polacrilex	NICOTINE POLACRILEX	AAFES/Your Military Exchanges	27308f6b-43b9-4b1d-af6b-7a39b79def03	2025-05-08	Warnings	Exact identifier application applno (ANDA): 078699 application number: ANDA078699
Nicotine Polacrilex	NICOTINE POLACRILEX	Lucy Goods, Inc.	23ca9fd2-41a0-4210-ad97-62ec84d79907	2025-04-28	Warnings	Exact identifier application applno (ANDA): 078699 application number: ANDA078699
Nicotine Polacrilex	NICOTINE POLACRILEX	Quitine LLC	9e46b967-1668-42a7-be87-225ded849395	2024-12-17	Warnings	Exact identifier application applno (ANDA): 078699 application number: ANDA078699

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	d60f90a5-10ea-442b-9ec5-2f2a69ec6441	2
311975	nicotine polacrilex 4 MG Chewing Gum	PSN	d60f90a5-10ea-442b-9ec5-2f2a69ec6441	2
314119	nicotine 2 MG Chewing Gum	SCD	d60f90a5-10ea-442b-9ec5-2f2a69ec6441	2
311975	nicotine 4 MG Chewing Gum	SCD	d60f90a5-10ea-442b-9ec5-2f2a69ec6441	2
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	d60f90a5-10ea-442b-9ec5-2f2a69ec6441	2
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	d60f90a5-10ea-442b-9ec5-2f2a69ec6441	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72484-428-16	72484042816	160 BLISTER PACK in 1 CARTON (72484-428-16) > 1 GUM, CHEWING in 1 BLISTER PACK	160 blister pack	2018-10-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotine Polarilex Coated Mint 2 mg and 4 mg - Roman	Roman Health Ventures Inc.	2019-10-21	HUMAN OTC DRUG LABEL	2