Nicotine

Product NDC: 11822-0344
11-digit product format: 118220344
Labeler code: 11822
Product ID: 11822-0344_21806b88-889d-4f5c-b414-fb6b95d902bb
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Rite Aid Corporation
Application: ANDA077007
Marketing category: ANDA
Marketing start: 2006-02-24
Marketing end: 2026-12-31
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
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 · 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	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`caaa826d4ba7…`
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…`

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

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
9e411b49-c8c4-43f8-a402-5ca2d96db131	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
11822-0344-0	Nicotine	27 in 1 CONTAINER	LOZENGE	27	7
11822-0344-0	Nicotine	4 in 1 CARTON	LOZENGE	4	7
11822-0344-1	Nicotine	24 in 1 CONTAINER	LOZENGE	24	7
11822-0344-1	Nicotine	3 in 1 CARTON	LOZENGE	3	7
11822-0344-5	Nicotine	7 in 1 CARTON	LOZENGE	7	7
11822-0344-5	Nicotine	24 in 1 CONTAINER	LOZENGE	24	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]	3
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]	3
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]	3
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]	3
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]	3
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-0344	NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]	6	Current NDC, Legacy NDC, 6 package rows	20230720_9e411b49-c8c4-43f8-a402-5ca2d96db131.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 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	09bc9f57-fed2-42d9-b4f2-2b71b8baa0a9	2026-09-09	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	c94d46b1-f526-4af0-8f7c-8261b9ed6841	2026-09-09	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine	NICOTINE POLACRILEX	Sixarp, LLC	5a94092b-f80e-c656-e063-6294a90ab15a	2026-09-03	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
QUITINE NICOTINE	NICOTINE POLACRILEX	QUITINE LLC	2e24f6d7-957e-4c7c-a486-8a1c1b47d53f	2026-08-31	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	8430a12b-4a7b-48a1-aa8f-7e55c5fde3c0	2026-08-28	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
NICOTINE	NICOTINE POLACRILEX	Walgreen Company	5dd116ea-d031-439c-b06c-2f77230bc446	2026-08-20	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	e40a534e-8083-454d-9667-826bfbac397c	2026-08-19	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	bc1b6b41-d069-470e-90ca-a441ab97f96a	2026-08-18	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	9ba85e0a-bcb7-4803-8d21-0eb93768cb3a	2026-08-07	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Quitine Nicotine	NICOTINE POLACRILEX	QUITINE LLC	4cc32b8c-6316-4d4b-8fa9-ef640464ca69	2026-08-06	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
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
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	21014e98-2c7c-4cc6-8595-a717910710a4	2026-06-26	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	fd9ce0e2-b159-4e0d-a76e-7223d36810fb	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

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	9e411b49-c8c4-43f8-a402-5ca2d96db131	7
359817	nicotine 2 MG Oral Lozenge	SCD	9e411b49-c8c4-43f8-a402-5ca2d96db131	7
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	9e411b49-c8c4-43f8-a402-5ca2d96db131	7
359817	nicotine 2 MG Troche	SY	9e411b49-c8c4-43f8-a402-5ca2d96db131	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-0344-0	11822034400	4 CONTAINER in 1 CARTON (11822-0344-0) / 27 LOZENGE in 1 CONTAINER	4 container	2009-09-03	0000-00-00	No	No	Current
11822-0344-1	11822034401	3 CONTAINER in 1 CARTON (11822-0344-1) / 24 LOZENGE in 1 CONTAINER	3 container	2011-09-02	0000-00-00	No	No	Current
11822-0344-5	11822034405	7 CONTAINER in 1 CARTON (11822-0344-5) / 24 LOZENGE in 1 CONTAINER	7 container	2023-07-19	2026-10-01	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rite Aid Corporation Nicotine Lozenges Drug Facts	Rite Aid Corporation	2026-05-27	HUMAN OTC DRUG LABEL	7