Rugby Nicotine Polacrilex Gum, Mint Flavor

Product NDC: 70518-1048
11-digit product format: 705181048
Labeler code: 70518
Product ID: 70518-1048_a709fee8-ba73-c798-e053-2995a90a02f4
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: BUCCAL
Labeler: REMEDYREPACK INC.
Application: ANDA076568
Marketing category: ANDA
Marketing start: 2019-08-14
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 4 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-1048		D	Discontinued by firm		2026-08-03
excluded package	package	70518-1048	70518-1048-0	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1048-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1048-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1048-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1048-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1048-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1048-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1048-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1048-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1048-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1048-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-1048-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-1048-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076568-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2004-07-29

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	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076568-002	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Polacrilex MINT	NICOTINE POLACRILEX	Walgreens	53c5ae28-5638-4217-9080-2bceba9a8885	2026-05-19	Warnings	Exact identifier application applno (ANDA): 076568 application number: ANDA076568
Nicotine Polacrilex	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	51cf7563-889d-4726-8f4c-e8efe0290432	2026-03-18	Warnings	Exact identifier application applno (ANDA): 076568 application number: ANDA076568
Nicotine Polacrilex	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	03d0bfa1-cb23-408a-8d8e-24aa0e05bf4f	2026-03-18	Warnings	Exact identifier application applno (ANDA): 076568 application number: ANDA076568
Rugby Nicotine Polacrilex Gum, Mint Flavor	NICOTINE POLACRILEX	Rugby Laboratories	0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25	2026-02-26	Warnings	Exact identifier application applno (ANDA): 076568 application number: ANDA076568

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6M3C89ZY6R	NICOTINE	54-11-5	NICOTINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1048-0	70518104800	30 GUM, CHEWING in 1 BLISTER PACK (70518-1048-0)	2019-08-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotine Polacrilex Gum 2 mg and 4 mg MINT - Rugby	REMEDYREPACK INC.	2020-06-01	HUMAN OTC DRUG LABEL	2