Topcare Nicotine

Product NDC: 36800-460
11-digit product format: 368000460
Labeler code: 36800
Product ID: 36800-460_574b6739-180d-49b8-80c9-7df963c37e79
Type: HUMAN OTC DRUG
Nonproprietary name: nicotine polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA206394
Marketing category: ANDA
Marketing start: 2023-07-28
Substance: NICOTINE
Active strength: 2 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 43.

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
A206394-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2016-12-15

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 · 43 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	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`f41ea6bd6efb…`

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: Topcare Nicotine
Listing expiration: 2027-12-31

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
314119	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
cb306cdf-bab5-4b13-986b-21ade4764f00	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
36800-460-25	Topcare Nicotine	110 in 1 CARTON	GUM, CHEWING	110		4
36800-460-25	Topcare Nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-460	TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]	3	Current NDC, 2 package rows	20250426_cb306cdf-bab5-4b13-986b-21ade4764f00.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 2 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE	H E B	da70bf12-4454-40ac-8cfd-8b7697496d55	2026-06-19	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
signature care nicotine	NICOTINE POLACRILEX	Safeway	da824d13-9dfa-41e5-a6ac-0081f5de74a8	2026-06-19	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
nicotine	NICOTINE POLACRILEX	Padagis Israel Pharmaceuticals Ltd	f9759891-7d3d-4714-8f8b-92d0a499e52e	2026-06-11	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
members mark nicotine	NICOTINE POLACRILEX	Sam's West Inc	8828d4f5-7b3a-4f1c-8f78-fa820ffa8441	2026-06-11	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
Members Mark Nicotine	NICOTINE POLACRILEX	Sam's West Inc	bb8ec4c2-7f1a-4069-9677-8bf645d18e32	2026-06-11	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
BLIP	NICOTINE POLACRILEX	Blip Products, Inc.	ad5fc90e-d3b4-4701-bfd8-1cda9087d09a	2026-06-11	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
GOOD SENSE NICOTINE	NICOTINE POLACRILEX	L. Perrigo Company	28843e89-9782-42bc-8afb-1059ef44d8f1	2026-05-11	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
Nicotine	NICOTINE POLACRILEX	Walgreen Company	7446369d-2fac-4c5a-a6bb-9e149abc4c15	2026-04-28	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
up and up coated cinnamon nicotine	NICOTINE POLACRILEX	Target Corporation	8e8884c9-69cb-424c-8ed0-ebd66d5bb175	2026-04-27	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
up and up nicotine	NICOTINE POLACRILEX	Target Corporation	3de22bc2-e648-4314-bfd2-37365f82aa43	2026-04-27	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
nicotine	NICOTINE POLACRILEX	Meijer, Inc.	f4ceda50-8204-4c37-9875-9374617cdf43	2026-04-24	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
UP AND UP COATED MINT FREEZE NICOTINE	NICOTINE POLACRILEX	Target Corporation	f14c065e-88bc-4fba-8a70-51e140afeb37	2026-04-17	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
nicotine	NICOTINE POLACRILEX	Walgreen Company	a1258f0a-24d2-40b0-8f44-06f2cafd7d26	2026-04-17	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
up and up uncoated mint nicotine	NICOTINE POLACRILEX	Target Corporation	816cc4f7-b7ef-4172-b16b-e9c1dc356482	2026-04-16	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
nicotine	NICOTINE POLACRILEX	Meijer, Inc.	34107c14-6ece-4a51-b53f-ee0099889e99	2026-04-14	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
good sense nicotine	NICOTINE POLACRILEX	L. Perrigo Company	ba373c62-65eb-43ad-88e3-bb2c13df588c	2026-04-10	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
nictoine gum	NICOTINE POLACRILEX	Rite Aid Corporation	6088eea3-f8f0-4f28-8d38-c2209f2d6626	2026-03-27	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
NICOTINE	NICOTINE POLACRILEX	HyVee Inc	b9257174-fbd4-453d-aa23-77d5a8f91b89	2026-03-11	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
NICOTINE	NICOTINE POLACRILEX	Walgreen Company	97fefc42-5c9d-453e-a0b6-dc7aac5ee8e1	2026-03-02	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	ef409dfa-94fa-4dfb-8916-e315bec9de34	2026-02-25	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394

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
314119	nicotine polacrilex 2 MG Chewing Gum	PSN	cb306cdf-bab5-4b13-986b-21ade4764f00	4
314119	nicotine 2 MG Chewing Gum	SCD	cb306cdf-bab5-4b13-986b-21ade4764f00	4
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	cb306cdf-bab5-4b13-986b-21ade4764f00	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
36800-460-25	36800046025	110 BLISTER PACK in 1 CARTON (36800-460-25) / 1 GUM, CHEWING in 1 BLISTER PACK	110 blister pack	2023-07-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Nicotine Gum Drug Facts	Topco Associates LLC	2026-02-12	HUMAN OTC DRUG LABEL	4