good sense nicotine

Product NDC: 68258-7992
11-digit product format: 682587992
Labeler code: 68258
Product ID: 68258-7992_40855932-0f9c-4ee0-96a5-4512c6ba9d66
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA077007
Marketing category: ANDA
Marketing start: 2006-12-27
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 4 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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	68258-7992		I	Inactivated by FDA		2026-10-05
excluded package	package	68258-7992	68258-7992-7	I	Inactivated by FDA		2026-10-05

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 · 44 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	68258-7992-7	`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	68258-7992-7	`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	68258-7992-7	`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	68258-7992-7	`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	68258-7992-7	`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	68258-7992-7	`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	68258-7992-7	`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	68258-7992-7	`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	68258-7992-7	`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	68258-7992-7	`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	68258-7992-7	`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	68258-7992-7	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68258-7992-7	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68258-7992-7	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68258-7992-7	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68258-7992-7	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68258-7992-7	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68258-7992-7	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-7992-7	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-7992-7	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-7992-7	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-7992-7	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077007-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2006-01-31
A077007-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2006-01-31

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 3 · 86 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	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-7992-7	2019-11-13	C162847	48780-1	97449f38-c23f-f6ea-e053-dbdaa90aa703	Perrigo Nicotine Polacrilex Lozenge 4 mg (nicotine) Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-7992-7	good sense nicotine	3 in 1 CARTON	LOZENGE	3		1
68258-7992-7	good sense nicotine	24 in 1 VIAL	LOZENGE	24		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]	1
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]	1
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]	1
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]	1
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]	1
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-7992	GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 2 package rows	20120313_26bfbdad-d67a-41b9-803d-967d438a2672.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 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	09bc9f57-fed2-42d9-b4f2-2b71b8baa0a9	2026-09-09	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	c94d46b1-f526-4af0-8f7c-8261b9ed6841	2026-09-09	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine	NICOTINE POLACRILEX	Sixarp, LLC	5a94092b-f80e-c656-e063-6294a90ab15a	2026-09-03	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
QUITINE NICOTINE	NICOTINE POLACRILEX	QUITINE LLC	2e24f6d7-957e-4c7c-a486-8a1c1b47d53f	2026-08-31	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	8430a12b-4a7b-48a1-aa8f-7e55c5fde3c0	2026-08-28	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
NICOTINE	NICOTINE POLACRILEX	Walgreen Company	5dd116ea-d031-439c-b06c-2f77230bc446	2026-08-20	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	e40a534e-8083-454d-9667-826bfbac397c	2026-08-19	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	bc1b6b41-d069-470e-90ca-a441ab97f96a	2026-08-18	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	9ba85e0a-bcb7-4803-8d21-0eb93768cb3a	2026-08-07	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Quitine Nicotine	NICOTINE POLACRILEX	QUITINE LLC	4cc32b8c-6316-4d4b-8fa9-ef640464ca69	2026-08-06	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	00b40bb3-3785-4a53-804e-633795e87f71	2026-07-20	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
EQUATE NICOTINE	NICOTINE POLACRILEX	WALMART INC.	b6379f86-1528-465d-9527-bd2fead0068f	2026-07-15	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	5c89061b-1452-4962-9f25-212f2ae8e41e	2026-07-13	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine coated	NICOTINE POLACRILEX	Publix Super Markets Inc	a0113a1d-3691-4f18-9950-ae6d8d7d19ea	2026-07-10	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
NICOTINE	NICOTINE POLACRILEX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0ef9e55d-83e0-4ba5-a905-8cddb0db0019	2026-07-09	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine coated	NICOTINE POLACRILEX	Publix Super Markets Inc	8cb5577b-48c0-47f8-8979-0ab54d713045	2026-07-09	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	Kroger Company	35f45900-af2e-4b74-9772-8beb55236457	2026-06-26	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	21014e98-2c7c-4cc6-8595-a717910710a4	2026-06-26	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	fd9ce0e2-b159-4e0d-a76e-7223d36810fb	2026-06-26	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	Kroger Company	0ef57432-471d-4c7a-b8be-0f898f01d197	2026-06-26	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007

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
359818	nicotine 4 MG Oral Lozenge	PSN	26bfbdad-d67a-41b9-803d-967d438a2672	1
359818	nicotine 4 MG Oral Lozenge	SCD	26bfbdad-d67a-41b9-803d-967d438a2672	1
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	26bfbdad-d67a-41b9-803d-967d438a2672	1
359818	nicotine 4 MG Troche	SY	26bfbdad-d67a-41b9-803d-967d438a2672	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-7992-7	68258799207	3 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perrigo Nicotine Polacrilex Lozenge 4 mg (nicotine) Drug Facts	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-03-07	HUMAN OTC DRUG LABEL	1