nicotine polacrilex

Product NDC: 37808-948
Requested package NDC: 37808-948-10
11-digit product format: 378080948
Labeler code: 37808
Product ID: 37808-948_f43e624c-e96a-486f-94df-cd6cb23f9934
Type: HUMAN OTC DRUG
Nonproprietary name: nicotine
Dosage form: LOZENGE
Route: ORAL
Labeler: H E B
Application: ANDA077007
Marketing category: ANDA
Marketing start: 2019-05-10
Substance: NICOTINE
Active strength: 4 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
A077007-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2006-01-31
A077007-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2006-01-31

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 · 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	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: nicotine polacrilex
Listing expiration: 2027-12-31

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
d1f1453d-75a8-4c54-a28a-fb631db54ba4	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
37808-948-03	nicotine polacrilex	1 in 1 CARTON	LOZENGE	1	3
37808-948-03	nicotine polacrilex	24 in 1 CONTAINER	LOZENGE	24	3
37808-948-10	nicotine polacrilex	27 in 1 CONTAINER	LOZENGE	27	3
37808-948-10	nicotine polacrilex	4 in 1 CARTON	LOZENGE	4	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-948	NICOTINE POLACRILEX (NICOTINE) LOZENGE [H E B]	2	Current NDC, Legacy NDC, 4 package rows	20190521_d1f1453d-75a8-4c54-a28a-fb631db54ba4.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 4 · 75 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	00b40bb3-3785-4a53-804e-633795e87f71	2026-07-20	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
EQUATE NICOTINE	NICOTINE POLACRILEX	WALMART INC.	b6379f86-1528-465d-9527-bd2fead0068f	2026-07-15	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	5c89061b-1452-4962-9f25-212f2ae8e41e	2026-07-13	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine coated	NICOTINE POLACRILEX	Publix Super Markets Inc	a0113a1d-3691-4f18-9950-ae6d8d7d19ea	2026-07-10	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
NICOTINE	NICOTINE POLACRILEX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0ef9e55d-83e0-4ba5-a905-8cddb0db0019	2026-07-09	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine coated	NICOTINE POLACRILEX	Publix Super Markets Inc	8cb5577b-48c0-47f8-8979-0ab54d713045	2026-07-09	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	Kroger Company	35f45900-af2e-4b74-9772-8beb55236457	2026-06-26	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	Kroger Company	0ef57432-471d-4c7a-b8be-0f898f01d197	2026-06-26	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
berkley and jensen nicotine	NICOTINE POLACRILEX	BJWC	3a408d89-974f-4a20-aee9-fb1fe0a7ef3e	2026-06-25	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
NICOTINE	NICOTINE POLACRILEX	Publix Super Markets Inc	d043920e-d795-4eff-aadd-4c81b01503ea	2026-06-22	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
NICOTINE	NICOTINE POLACRILEX	H E B	9c0122e4-7b5b-40c6-a981-1f7853bf3ce7	2026-06-18	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	8b24aefd-1881-4126-9188-29896a17a06d	2026-06-03	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	HyVee Inc	7e391e5d-a715-42ae-8c4d-0a7d1a859989	2026-06-03	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine	NICOTINE POLACRILEX	CVS Pharmacy	4bc94e0b-189f-47b0-826c-2ccf6c4a0e3a	2026-06-01	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	9e411b49-c8c4-43f8-a402-5ca2d96db131	2026-05-27	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	0ac7f87a-63f4-4d74-ba5b-d1444803b100	2026-05-11	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	Walgreen Company	77688e56-4293-4f37-9f48-fe09267ff619	2026-05-07	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	53387dd6-28c0-412d-bc74-4d323c8d5e11	2026-04-16	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
NICOTINE	NICOTINE POLACRILEX	HyVee Inc	6415ebf4-5b6f-4811-997d-27c76893bc04	2026-03-19	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine lozenge	NICOTINE POLACRILEX	H E B	db78d030-7abf-494f-94ca-4a385f519faf	2026-02-27	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007

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	d1f1453d-75a8-4c54-a28a-fb631db54ba4	3
359818	nicotine 4 MG Oral Lozenge	SCD	d1f1453d-75a8-4c54-a28a-fb631db54ba4	3
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	d1f1453d-75a8-4c54-a28a-fb631db54ba4	3
359818	nicotine 4 MG Troche	SY	d1f1453d-75a8-4c54-a28a-fb631db54ba4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-948-10	37808094810	4 CONTAINER in 1 CARTON (37808-948-10) / 27 LOZENGE in 1 CONTAINER	4 container	2019-05-10	0000-00-00	No	No	Current