Nicotine

Product NDC: 57237-320
11-digit product format: 572370320
Labeler code: 57237
Product ID: 57237-320_02faa0ad-b311-4bfa-9e0f-b085939d7063
Type: HUMAN OTC DRUG
Nonproprietary name: nicotine polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA207868
Marketing category: ANDA
Marketing start: 2023-08-10
Substance: NICOTINE
Active strength: 2 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A207868-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2019-02-07
A207868-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2019-02-07

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	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207868-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207868-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2019-02-07	`74a2ff9319b5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A207868-001	PC	2019-10-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207868-002	PC	2019-10-01	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A207868-001	PC	2019-10-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207868-002	PC	2019-10-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207868-001	PC	2019-10-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207868-002	PC	2019-10-01	`b00525d2431f…`

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
Listing expiration: 2026-12-31

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
359817	Internal RxNorm lookup
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
05990040-5bd7-4622-8fe3-2d7573904dfa	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
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	SPL version
57237-320-27	NicotineMini	27 in 1 BOTTLE, PLASTIC	LOZENGE	27	3
57237-320-42	NicotineMini	1 in 1 BOX	LOZENGE	1	3
57237-320-42	NicotineMini	24 in 1 BOTTLE, PLASTIC	LOZENGE	24	3
57237-320-72	NicotineMini	3 in 1 BOX	LOZENGE	3	3
57237-320-72	NicotineMini	24 in 1 BOTTLE, PLASTIC	LOZENGE	24	3
57237-320-81	NicotineMini	3 in 1 BOX	LOZENGE	3	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-320-72	EA - Each	57237-320	7f840bda-52b0-46e4-a3f2-a6a37ba4d6cf	1	2023-09-05
57237-320-81	EA - Each	57237-320	a30a4078-4f2d-4746-81e0-bd5790ed0b26	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-320	NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [RISING PHARMA HOLDINGS, INC.]	2	Current NDC, 6 package rows	20241011_05990040-5bd7-4622-8fe3-2d7573904dfa.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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Mini	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ab184645-6fff-40cf-9859-4b8dec9098b2	2023-03-20	Warnings	Exact identifier application applno (ANDA): 207868 application number: ANDA207868
Nicotine Mini	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ab1df1b4-a831-4de2-be87-38b9cd589db9	2023-03-20	Warnings	Exact identifier application applno (ANDA): 207868 application number: ANDA207868
Nicotine Mini	NICOTINE POLACRILEX	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	4eeaf22c-a839-49c5-b099-77321d590d06	2022-12-06	Warnings	Exact identifier application applno (ANDA): 207868 application number: ANDA207868
Nicotine	NICOTINE POLACRILEX	CVS Pharmacy	7fa848c6-3a4a-41f3-b927-1b26b6232e3a	2022-11-22	Warnings	Exact identifier application applno (ANDA): 207868 application number: ANDA207868
Nicotine Mini	NICOTINE POLACRILEX	Cardinal Health (Leader) 70000	71ee5a44-b451-4ecd-9fe7-8124b4dae1c5	2022-10-20	Warnings	Exact identifier application applno (ANDA): 207868 application number: ANDA207868
Nicotine Mini	NICOTINE POLACRILEX	Cardinal Health (Leader) 70000	6edf8c50-d3b9-469a-ad57-37c05e098862	2022-10-20	Warnings	Exact identifier application applno (ANDA): 207868 application number: ANDA207868

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
359817	nicotine 2 MG Oral Lozenge	PSN	05990040-5bd7-4622-8fe3-2d7573904dfa	3
359818	nicotine 4 MG Oral Lozenge	PSN	05990040-5bd7-4622-8fe3-2d7573904dfa	3
359817	nicotine 2 MG Oral Lozenge	SCD	05990040-5bd7-4622-8fe3-2d7573904dfa	3
359818	nicotine 4 MG Oral Lozenge	SCD	05990040-5bd7-4622-8fe3-2d7573904dfa	3
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	05990040-5bd7-4622-8fe3-2d7573904dfa	3
359817	nicotine 2 MG Troche	SY	05990040-5bd7-4622-8fe3-2d7573904dfa	3
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	05990040-5bd7-4622-8fe3-2d7573904dfa	3
359818	nicotine 4 MG Troche	SY	05990040-5bd7-4622-8fe3-2d7573904dfa	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
57237-320-27	57237032027	27 in 1 BOTTLE, PLASTIC				Historical
57237-320-42	57237032042	1 BOTTLE, PLASTIC in 1 BOX (57237-320-42) / 24 LOZENGE in 1 BOTTLE, PLASTIC	2023-08-10	No	No	Current
57237-320-72	57237032072	3 BOTTLE, PLASTIC in 1 BOX (57237-320-72) / 24 LOZENGE in 1 BOTTLE, PLASTIC	2023-08-10	No	No	Current
57237-320-81	57237032081	3 BOTTLE, PLASTIC in 1 BOX (57237-320-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC (57237-320-27)	2025-12-08	No	No	Current