nicotine

Product NDC: 37808-533
11-digit product format: 378080533
Labeler code: 37808
Product ID: 37808-533_56f142f0-fb0c-4e01-91a0-50ce317d8962
Type: HUMAN OTC DRUG
Nonproprietary name: nicotine
Dosage form: LOZENGE
Route: ORAL
Labeler: H E B
Application: ANDA090711
Marketing category: ANDA
Marketing start: 2019-04-16
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 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: 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 · 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
691f3f8d-7242-4855-b80b-4d5af0490b37	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	Strength	SPL version
37808-533-10	nicotine	27 in 1 CONTAINER	LOZENGE	27		2
37808-533-10	nicotine	4 in 1 CARTON	LOZENGE	4		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-533	NICOTINE LOZENGE [H E B]	2	Current NDC, Legacy NDC, 2 package rows	20190423_691f3f8d-7242-4855-b80b-4d5af0490b37.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
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	691f3f8d-7242-4855-b80b-4d5af0490b37	2
359817	nicotine 2 MG Oral Lozenge	SCD	691f3f8d-7242-4855-b80b-4d5af0490b37	2
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	691f3f8d-7242-4855-b80b-4d5af0490b37	2
359817	nicotine 2 MG Troche	SY	691f3f8d-7242-4855-b80b-4d5af0490b37	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-533-10	37808053310	4 CONTAINER in 1 CARTON (37808-533-10) / 27 LOZENGE in 1 CONTAINER	4 container	2019-04-16	0000-00-00	No	No	Current