Topcare nicotine

Product NDC: 36800-352
Requested package NDC: 36800-352-78
11-digit product format: 368000352
Labeler code: 36800
Product ID: 36800-352_b4c23c34-e1b4-43da-beda-daca6b9e46c1
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA078547
Marketing category: ANDA
Marketing start: 2010-01-28
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 2 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-352	36800-352-78	D	Discontinued by firm		2026-08-10

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078547-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2007-05-24

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 2 · 41 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	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-352-78	EA - Each	36800-352	f51bf93d-ea04-4c88-a18a-adf12cda9c33	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) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	189c13db-b4b7-4534-ae3c-1c52bb879e2b	2026-06-29	Warnings	Exact identifier application applno (ANDA): 078547 application number: ANDA078547
care one nicotine	NICOTINE POLACRILEX	American Sales Company	e9558a4e-a0ad-4391-9b9c-85edb61523c1	2026-06-17	Warnings	Exact identifier application applno (ANDA): 078547 application number: ANDA078547
Basic Care Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	a7e3da43-693b-44df-8566-4847edae9d61	2026-06-10	Warnings	Exact identifier application applno (ANDA): 078547 application number: ANDA078547
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	486400cd-f2ef-4e14-8cf7-37954e1ed4d4	2026-05-20	Warnings	Exact identifier application applno (ANDA): 078547 application number: ANDA078547
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	c5290759-84c0-4999-8222-d03a0b61bcd5	2026-04-27	Warnings	Exact identifier application applno (ANDA): 078547 application number: ANDA078547
good sense nicotine	NICOTINE POLACRILEX	L. Perrigo Company	8647dca6-676b-4279-8e20-17153feb9974	2026-01-19	Warnings	Exact identifier application applno (ANDA): 078547 application number: ANDA078547

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6M3C89ZY6R	NICOTINE	54-11-5	NICOTINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-352-78	36800035278	100 BLISTER PACK in 1 CARTON (36800-352-78) > 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2010-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Nicotine Polacrilex Gum USP 2 mg (nicotine) Drug Facts	Topco Associates LLC	2021-04-07	HUMAN OTC DRUG LABEL	6