Topcare Nicotine Polacrilex

Product NDC: 36800-344
11-digit product format: 368000344
Labeler code: 36800
Product ID: 36800-344_2491860b-a095-4eb9-abc1-ec4619c2c5e3
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA077007
Marketing category: ANDA
Marketing start: 2009-09-03
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 2 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	36800-344		I	Inactivated by FDA	2026-08-03
excluded package	package	36800-344	36800-344-05	I	Inactivated by FDA	2026-08-03
excluded package	package	36800-344	36800-344-06	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

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
36800-344-03	Topcare Nicotine Polacrilex	24 in 1 CONTAINER	LOZENGE	24	7
36800-344-05	Topcare Nicotine Polacrilex	3 in 1 CARTON	LOZENGE	3	7
36800-344-06	Topcare Nicotine Polacrilex	24 in 1 CONTAINER	LOZENGE	24	7
36800-344-06	Topcare Nicotine Polacrilex	4 in 1 CARTON	LOZENGE	4	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-344-03	EA - Each	36800-344	33464911-e144-4b38-8a00-43df44bfdf5c	1	2019-03-12
36800-344-05	EA - Each	36800-344	0a206a95-6bf6-42e5-9c51-4fe40d98c14b	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-344	TOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]	7	Legacy NDC, 4 package rows	20231208_01e90106-4f97-4ae4-8d48-3e5adffd716b.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
359817	nicotine 2 MG Oral Lozenge	PSN	01e90106-4f97-4ae4-8d48-3e5adffd716b	7
359817	nicotine 2 MG Oral Lozenge	SCD	01e90106-4f97-4ae4-8d48-3e5adffd716b	7
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	01e90106-4f97-4ae4-8d48-3e5adffd716b	7
359817	nicotine 2 MG Troche	SY	01e90106-4f97-4ae4-8d48-3e5adffd716b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-344-03	36800034403	24 in 1 CONTAINER						Historical
36800-344-05	36800034405	3 CONTAINER in 1 CARTON (36800-344-05) > 24 LOZENGE in 1 CONTAINER (36800-344-03)	3 container	2009-09-03	0000-00-00	No	No	Current
36800-344-06	36800034406	4 CONTAINER in 1 CARTON (36800-344-06) > 24 LOZENGE in 1 CONTAINER	4 container	2011-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Nicotine Polacrilex Lozenge 2 mg (nicotine) Drug Facts	Topco Associates LLC	2023-12-07	HUMAN OTC DRUG LABEL	7