quitine nicotine

Product NDC: 84720-854
11-digit product format: 847200854
Labeler code: 84720
Product ID: 84720-854_cc5080b8-4000-4afa-bace-51fc53ccd1b0
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: QUITINE LLC
Application: ANDA078546
Marketing category: ANDA
Marketing start: 2024-12-04
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
A078546-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2007-05-24

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	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: quitine nicotine
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 · 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
426e7bbc-cf58-4be0-a8e5-30a8f7ca5b48	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
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
84720-854-70	quitine nicotine	240 in 1 CARTON	GUM, CHEWING	240		3
84720-854-70	quitine nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84720-854	QUITINE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [QUITINE LLC]	2	Current NDC, 2 package rows	20241215_426e7bbc-cf58-4be0-a8e5-30a8f7ca5b48.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
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	b8cbb6a7-aeb4-48f3-a0ed-7ad803021752	2026-06-26	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	59ba5cba-be1e-4708-a9ab-01f43543bb5b	2026-06-19	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
Care One Nicotine	NICOTINE POLACRILEX	American Sales Company	78cf8b14-cdad-464c-afb5-9fc49ebc3921	2026-06-19	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	426e7bbc-cf58-4be0-a8e5-30a8f7ca5b48	2026-05-20	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546 ndc (product): 84720-854
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	0f1b3cc6-98df-4e34-91f3-dc251fe170f8	2026-04-28	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
Equate Nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	54c1a1d5-f7b4-4109-8887-02dc10bfd593	2025-09-16	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546

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	426e7bbc-cf58-4be0-a8e5-30a8f7ca5b48	3
311975	nicotine 4 MG Chewing Gum	SCD	426e7bbc-cf58-4be0-a8e5-30a8f7ca5b48	3
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	426e7bbc-cf58-4be0-a8e5-30a8f7ca5b48	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84720-854-70	84720085470	240 BLISTER PACK in 1 CARTON (84720-854-70) / 1 GUM, CHEWING in 1 BLISTER PACK	240 blister pack	2024-12-04	No	No	Current