nicotine

Product NDC: 41250-700
11-digit product format: 412500700
Labeler code: 41250
Product ID: 41250-700_352fb71d-be46-4d6f-a70d-c42db3e2276a
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Meijer Distribution Inc
Application: ANDA090711
Marketing category: ANDA
Marketing start: 2009-09-11
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
A090711-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2009-07-10
A090711-002	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	A090711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090711-002	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	A090711-001	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	A090711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090711-002	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	A090711-001	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	A090711-002	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	A090711-001	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	A090711-002	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	A090711-001	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	A090711-002	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	A090711-001	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	A090711-002	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	A090711-001	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	A090711-002	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	A090711-001	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	A090711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090711-002	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	A090711-001	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	A090711-002	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	A090711-001	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	A090711-002	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	A090711-001	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	A090711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090711-002	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	A090711-001	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	A090711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090711-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090711-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2009-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090711-002	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
3566423d-3ddb-4913-9da5-fb43680f0efc	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
41250-700-03	nicotine	24 in 1 CONTAINER	LOZENGE	24	8
41250-700-05	nicotine	3 in 1 CARTON	LOZENGE	3	8
41250-700-09	nicotine	27 in 1 CONTAINER	LOZENGE	27	8
41250-700-10	nicotine	4 in 1 CARTON	LOZENGE	4	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]	2
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]	2
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]	2
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]	2
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]	2
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-700	NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]	6	Current NDC, Legacy NDC, 4 package rows	20250430_3566423d-3ddb-4913-9da5-fb43680f0efc.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NICOTINE	NICOTINE POLACRILEX	Amazon.com Services LLC	ec341a77-5b62-4980-8d31-27c12ae92561	2026-07-28	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	a9402b4b-f8e6-4e96-ad45-5875dfd0c889	2026-07-10	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	8c296647-00a1-43d0-acd1-7c1e92f36883	2026-07-09	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
Nicotine	NICOTINE POLACRILEX	Kroger Company	e4a7cf2a-5fd9-4390-8517-e532900ff81c	2026-06-26	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	f1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c	2026-05-27	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	dd334b2c-bbae-48e7-8f3d-2706d325f600	2026-05-26	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	6020abb5-2a4f-4602-8014-e2b4e462c05f	2026-05-15	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	18ee7d8b-7b18-404e-8e62-c10355bb0a26	2026-04-25	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	3566423d-3ddb-4913-9da5-fb43680f0efc	2026-04-08	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711 ndc (product): 41250-700
Nicotine	NICOTINE POLACRILEX	Walgreen Company	74f306d4-2a71-48c9-ab98-378260507a9d	2026-03-01	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	99da90fa-00ff-4c62-91a2-1e434dadaf41	2026-02-12	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
topcare nicotine polacrilex	NICOTINE POLACRILEX	Topco Associates LLC	d0403746-f866-42da-ad66-2a686c8bce01	2026-02-11	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
Nicotine	NICOTINE POLACRILEX	Kroger Company	69a61101-df32-444e-a49a-eccfeebfb20e	2025-12-11	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
QUITINE NICOTINE	NICOTINE POLACRILEX	QUITINE LLC	5d23992f-a010-4604-b64c-94ab6b134e6d	2025-12-04	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
Quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	90232b4e-cbf4-4d03-973a-41f4ebb4e5de	2025-12-04	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
Basic Care Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	47561b44-572e-4ca0-b91c-db0706131363	2025-08-25	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
nicotine	NICOTINE POLACRILEX	Walgreen Company	4a81d378-009d-43a9-a895-e371ffa700e9	2025-03-19	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
Nicotine	NICOTINE POLACRILEX	CVS Pharmacy	5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b2	2024-07-08	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
NICOTINE	NICOTINE POLACRILEX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	114418c4-6f39-46ce-912c-ac3687b7b75e	2024-07-03	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711
up and up cherry nicotine	NICOTINE POLACRILEX	Target Corporation	85d82812-9f90-401f-8a2c-729cbfdf4c78	2024-03-29	Warnings	Exact identifier application applno (ANDA): 090711 application number: ANDA090711

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	3566423d-3ddb-4913-9da5-fb43680f0efc	8
359817	nicotine 2 MG Oral Lozenge	SCD	3566423d-3ddb-4913-9da5-fb43680f0efc	8
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	3566423d-3ddb-4913-9da5-fb43680f0efc	8
359817	nicotine 2 MG Troche	SY	3566423d-3ddb-4913-9da5-fb43680f0efc	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-700-03	41250070003	24 in 1 CONTAINER						Historical
41250-700-05	41250070005	3 CONTAINER in 1 CARTON (41250-700-05) / 24 LOZENGE in 1 CONTAINER (41250-700-03)	3 container	2009-09-11	0000-00-00	No	No	Current
41250-700-09	41250070009	27 in 1 CONTAINER						Historical
41250-700-10	41250070010	4 CONTAINER in 1 CARTON (41250-700-10) / 27 LOZENGE in 1 CONTAINER (41250-700-09)	4 container	2026-04-07		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Nicotine Lozenge Drug Facts	Meijer Distribution Inc	2026-04-08	HUMAN OTC DRUG LABEL	8