Rugby Nicotine Polacrilex Gum, Mint Flavor

Product NDC: 0536-1362
11-digit product format: 005361362
Labeler code: 0536
Product ID: 0536-1362_3264fa2c-9a96-4aff-979b-d83a990d0fcf
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: BUCCAL
Labeler: Rugby Laboratories
Application: ANDA076569
Marketing category: ANDA
Marketing start: 2004-07-29
Substance: NICOTINE
Active strength: 2 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0536-1362		D	Discontinued by firm	2026-09-14
excluded package	package	0536-1362	0536-1362-06	D	Discontinued by firm	2026-09-14
excluded package	package	0536-1362	0536-1362-23	D	Discontinued by firm	2026-09-14
excluded package	package	0536-1362	0536-1362-34	D	Discontinued by firm	2026-09-14

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 · 48 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	0536-1362-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0536-1362-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0536-1362-23	`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	0536-1362-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0536-1362-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0536-1362-23	`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	0536-1362-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0536-1362-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0536-1362-23	`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	0536-1362-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0536-1362-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0536-1362-23	`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	0536-1362-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0536-1362-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0536-1362-23	`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	0536-1362-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0536-1362-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0536-1362-23	`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	0536-1362-34	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0536-1362-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0536-1362-23	`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	0536-1362-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0536-1362-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0536-1362-23	`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	0536-1362-34	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0536-1362-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0536-1362-23	`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	0536-1362-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0536-1362-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0536-1362-23	`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	0536-1362-34	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0536-1362-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0536-1362-23	`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	0536-1362-34	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0536-1362-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0536-1362-23	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076569-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG 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 · 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	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076569-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-07-29	`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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	2 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
0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	SPL version
0536-1362-06	Rugby Nicotine Polacrilex Gum, Mint Flavor	5 in 1 CARTON	GUM, CHEWING	5	18
0536-1362-06	Rugby Nicotine Polacrilex Gum, Mint Flavor	10 in 1 BLISTER PACK	GUM, CHEWING	10	18
0536-1362-23	Rugby Nicotine Polacrilex Gum, Mint Flavor	11 in 1 CARTON	GUM, CHEWING	11	18
0536-1362-23	Rugby Nicotine Polacrilex Gum, Mint Flavor	10 in 1 BLISTER PACK	GUM, CHEWING	10	18
0536-1362-34	Rugby Nicotine Polacrilex Gum, Mint Flavor	2 in 1 CARTON	GUM, CHEWING	2	18
0536-1362-34	Rugby Nicotine Polacrilex Gum, Mint Flavor	10 in 1 BLISTER PACK	GUM, CHEWING	10	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1362-06	EA - Each	0536-1362	f6aa756d-b9bf-4a97-9457-55210ab98cf2	1	2013-02-13
0536-1362-23	EA - Each	0536-1362	b9e570a5-cd24-4c9b-bf29-fd400f0f6ba4	1	2013-02-13
0536-1362-34	EA - Each	0536-1362	eebac00b-7910-4f44-9425-2020c54654e7	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]	2
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]	2
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]	2
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]	2
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]	2
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0536-1362	RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES, INC.]	16	Current NDC, Legacy NDC, 6 package rows	20241219_0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	Cardinal Health 107, LLC	ebab2c3a-4fda-40d6-8f54-972e1c6ee69a	2026-08-24	Warnings	Exact identifier application applno (ANDA): 076569 application number: ANDA076569
Nicotine	NICOTINE POLACRILEX	Rugby Laboratories	0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25	2026-07-10	Warnings	Exact identifier application applno (ANDA): 076569 application number: ANDA076569 ndc (product): 0536-1362
Nicotine Polacrilex MINT	NICOTINE POLACRILEX	Walgreens	53c5ae28-5638-4217-9080-2bceba9a8885	2026-05-19	Warnings	Exact identifier application applno (ANDA): 076569 application number: ANDA076569
Nicotine	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	5efd7a3c-b36c-4355-a646-bfeb7ba30ce5	2026-03-17	Warnings	Exact identifier application applno (ANDA): 076569 application number: ANDA076569
Rugby Nicotine Polacrilex Gum, Mint Flavor	NICOTINE POLACRILEX	A-S Medication Solutions	7b70162e-0087-466f-9b8b-8289b6e90e39	2025-09-23	Warnings	Exact identifier application applno (ANDA): 076569 application number: ANDA076569
Rugby Nicotine Polacrilex Gum, Mint Flavor	NICOTINE POLACRILEX	ATLANTIC BIOLOGICALS CORP.	62609a8d-bcbe-420c-aed8-edfdf022ff26	2025-06-27	Warnings	Exact identifier application applno (ANDA): 076569 application number: ANDA076569

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	0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25	18
311975	nicotine polacrilex 4 MG Chewing Gum	PSN	0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25	18
314119	nicotine 2 MG Chewing Gum	SCD	0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25	18
311975	nicotine 4 MG Chewing Gum	SCD	0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25	18
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25	18
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25	18
314119	nicotine polacrilex 2 MG Chewing Gum	PSN	7b70162e-0087-466f-9b8b-8289b6e90e39	16
314119	nicotine 2 MG Chewing Gum	SCD	7b70162e-0087-466f-9b8b-8289b6e90e39	16
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	7b70162e-0087-466f-9b8b-8289b6e90e39	16
314119	nicotine polacrilex 2 MG Chewing Gum	PSN	62609a8d-bcbe-420c-aed8-edfdf022ff26	4
314119	nicotine 2 MG Chewing Gum	SCD	62609a8d-bcbe-420c-aed8-edfdf022ff26	4
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	62609a8d-bcbe-420c-aed8-edfdf022ff26	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-1362-06	00536136206	5 BLISTER PACK in 1 CARTON (0536-1362-06) / 10 GUM, CHEWING in 1 BLISTER PACK	5 blister pack	2004-07-29	0000-00-00	No	No	Current
0536-1362-23	00536136223	11 BLISTER PACK in 1 CARTON (0536-1362-23) / 10 GUM, CHEWING in 1 BLISTER PACK	11 blister pack	2004-07-29	0000-00-00	No	No	Current
0536-1362-34	00536136234	2 BLISTER PACK in 1 CARTON (0536-1362-34) / 10 GUM, CHEWING in 1 BLISTER PACK	2 blister pack	2004-07-29	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	Cardinal Health 107, LLC	2026-08-24	HUMAN OTC DRUG LABEL	1
Nicotine Polacrilex Gum 2 mg and 4 mg MINT - Rugby	Rugby Laboratories	2026-07-10	HUMAN OTC DRUG LABEL	20
Nicotine Polacrilex Gum 2 mg and 4 mg MINT - Rugby	A-S Medication Solutions	2025-09-23	HUMAN OTC DRUG LABEL	16
Nicotine Polacrilex Gum 2 mg and 4 mg MINT - Rugby	ATLANTIC BIOLOGICALS CORP.	2025-06-27	HUMAN OTC DRUG LABEL	4