Nicotine

Product NDC: 0363-0979
11-digit product format: 003630979
Labeler code: 0363
Product ID: 0363-0979_c5269688-b2df-4261-a5df-fc9107a496f7
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Walgreens
Application: ANDA210711
Marketing category: ANDA
Marketing start: 2021-06-25
Marketing end: 2027-02-25
Substance: NICOTINE
Active strength: 4 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A210711-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2019-10-31
A210711-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2019-10-31

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-10-31	`4b0b4de00fa7…`

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
Brand name suffix: Mini

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
359818	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
2af56565-7e28-4915-ad60-49570c98a246	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0979-27	NicotineMini	27 in 1 BOTTLE, PLASTIC	LOZENGE	27	5
0363-0979-81	NicotineMini	27 in 1 BOTTLE, PLASTIC	LOZENGE	27	5
0363-0979-81	NicotineMini	3 in 1 BOX	LOZENGE	3	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0979	NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [WALGREENS]	4	Current NDC, Legacy NDC, 3 package rows	20240223_2af56565-7e28-4915-ad60-49570c98a246.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	P & L Development, LLC	30e00817-75ff-43db-901c-c180e6730901	2026-08-06	Warnings	Exact identifier application applno (ANDA): 210711 application number: ANDA210711
Nicotine Mini	NICOTINE POLACRILEX	P & L Development, LLC	3623455a-3f00-41d3-b17e-86a016da7047	2026-08-06	Warnings	Exact identifier application applno (ANDA): 210711 application number: ANDA210711
Nicotine Mini	NICOTINE POLACRILEX	Walgreens	06455f66-da8e-4be5-9069-6840f93d6d77	2026-02-10	Warnings	Exact identifier application applno (ANDA): 210711 application number: ANDA210711
Nicotine Mini	NICOTINE POLACRILEX	Walgreens	2af56565-7e28-4915-ad60-49570c98a246	2026-02-04	Warnings	Exact identifier application applno (ANDA): 210711 application number: ANDA210711 ndc (product): 0363-0979
Mini Nicotine	NICOTINE POLACRILEX	CVS Pharmacy	89e2a6b9-e759-4c18-a04d-d6fc9f264575	2026-01-29	Warnings	Exact identifier application applno (ANDA): 210711 application number: ANDA210711
Nicotine	NICOTINE POLACRILEX	Walgreens	446c857f-2380-4019-9a82-9fb9ee060d08	2024-02-21	Warnings	Exact identifier application applno (ANDA): 210711 application number: ANDA210711
Nicotine	NICOTINE POLACRILEX	Walgreens	19bd0eb4-0cd6-4979-bef6-eedbd4d5de88	2024-02-20	Warnings	Exact identifier application applno (ANDA): 210711 application number: ANDA210711
Nicotine Sugar Free	NICOTINE POLACRILEX	CVS Pharmacy	8986c712-6399-450e-8178-01fef29ebc52	2023-12-22	Warnings	Exact identifier application applno (ANDA): 210711 application number: ANDA210711

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	2af56565-7e28-4915-ad60-49570c98a246	5
359818	nicotine 4 MG Oral Lozenge	SCD	2af56565-7e28-4915-ad60-49570c98a246	5
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	2af56565-7e28-4915-ad60-49570c98a246	5
359818	nicotine 4 MG Troche	SY	2af56565-7e28-4915-ad60-49570c98a246	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0979-27	00363097927	27 LOZENGE in 1 BOTTLE, PLASTIC (0363-0979-27)	27 lozenge	2021-06-25	2027-02-25	No	No	Historical
0363-0979-81	00363097981	3 BOTTLE, PLASTIC in 1 BOX (0363-0979-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC		2021-06-25	2027-02-25	No	No	Current