nicotine

Product NDC: 41250-201
11-digit product format: 412500201
Labeler code: 41250
Product ID: 41250-201_ba98e47a-d334-4f96-96ab-3b0e622215aa
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine polarilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Meijer Distribution Inc
Application: ANDA090821
Marketing category: ANDA
Marketing start: 2010-01-15
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A090821-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2009-07-10
A090821-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2009-07-10

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 · 82 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	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090821-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090821-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`782e0a99824c…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
359817	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
9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
41250-201-03	nicotine	24 in 1 CONTAINER	LOZENGE	24	10
41250-201-05	nicotine	3 in 1 CARTON	LOZENGE	3	10
41250-201-09	nicotine	27 in 1 CONTAINER	LOZENGE	27	10
41250-201-10	nicotine	4 in 1 CARTON	LOZENGE	4	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]	3
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]	3
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]	3
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]	3
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]	3
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]	3
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-201	NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]	8	Current NDC, Legacy NDC, 4 package rows	20250507_9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	cd17f3b4-dddd-4387-9fb1-1efa32ba1d2b	2026-07-24	Warnings	Exact identifier application applno (ANDA): 090821 application number: ANDA090821
nicotine	NICOTINE POLACRILEX	CVS Pharmacy	ab1407e3-9092-438c-b684-8194e4ee71af	2026-07-23	Warnings	Exact identifier application applno (ANDA): 090821 application number: ANDA090821
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	ec88f367-ea8d-4bb9-80a6-71ba68412d38	2026-05-27	Warnings	Exact identifier application applno (ANDA): 090821 application number: ANDA090821
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	5bd02b68-84a2-43f1-9f01-fc4b8967e98a	2026-04-25	Warnings	Exact identifier application applno (ANDA): 090821 application number: ANDA090821
nicotine	NICOTINE POLARILEX	Meijer Distribution Inc	9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d	2026-04-20	Warnings	Exact identifier application applno (ANDA): 090821 application number: ANDA090821 ndc (product): 41250-201
nicotine	NICOTINE POLACRILEX	Walgreen Company	b1154b04-b3a6-4af9-a933-486c5501d46e	2025-11-11	Warnings	Exact identifier application applno (ANDA): 090821 application number: ANDA090821
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	4547ec2b-1543-4ce3-bdde-c0b292cdfcc1	2023-10-16	Warnings	Exact identifier application applno (ANDA): 090821 application number: ANDA090821
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	5fa9ffff-1511-474b-8342-f366b397de09	2023-10-13	Warnings	Exact identifier application applno (ANDA): 090821 application number: ANDA090821
Equate Nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	265e7411-45cd-4bd2-98fc-0401dfa52434	2023-07-28	Warnings	Exact identifier application applno (ANDA): 090821 application number: ANDA090821
Equate Nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	43a24aa7-ba1c-4c5d-9ec8-ed496e299e00	2023-07-28	Warnings	Exact identifier application applno (ANDA): 090821 application number: ANDA090821
Nicotine	NICOTINE POLACRILEX	Walgreen Company	d2572335-9c54-4745-9a11-eb9b8d34d0cd	2023-06-14	Warnings	Exact identifier application applno (ANDA): 090821 application number: ANDA090821

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	9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d	10
359817	nicotine 2 MG Oral Lozenge	SCD	9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d	10
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d	10
359817	nicotine 2 MG Troche	SY	9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-201-03	41250020103	1 CONTAINER in 1 CARTON (41250-201-03) > 24 LOZENGE in 1 CONTAINER	1 container	2010-01-15	0000-00-00	No	No	Current
41250-201-05	41250020105	3 CONTAINER in 1 CARTON (41250-201-05) / 24 LOZENGE in 1 CONTAINER (41250-201-03)	3 container	2010-01-15	0000-00-00	No	No	Current
41250-201-09	41250020109	27 in 1 CONTAINER						Historical
41250-201-10	41250020110	4 CONTAINER in 1 CARTON (41250-201-10) / 27 LOZENGE in 1 CONTAINER (41250-201-09)	4 container	2026-03-31		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Nicotine Lozenge Drug Facts	Meijer Distribution Inc	2026-04-20	HUMAN OTC DRUG LABEL	10