up and up nicotine

Product NDC: 11673-269
11-digit product format: 116730269
Labeler code: 11673
Product ID: 11673-269_13055fc5-202d-4207-9cdd-4d33bac46746
Type: HUMAN OTC DRUG
Nonproprietary name: nicotine
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Target Corporation
Application: ANDA206394
Marketing category: ANDA
Marketing start: 2019-03-14
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	11673-269		D	Discontinued by firm	2026-10-12
excluded package	package	11673-269	11673-269-06	D	Discontinued by firm	2026-10-12
excluded package	package	11673-269	11673-269-78	D	Discontinued by firm	2026-10-12

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11673-269-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11673-269-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11673-269-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11673-269-06	`f5e01cc5f278…`	`a2eaf40c39c3…`

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.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11673-269	UP AND UP NICOTINE (NICOTINE) GUM, CHEWING [TARGET CORPORATION]	4	Legacy NDC	20210414_eb8740c8-c09b-474d-b512-c90eadb71e18.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 · 42 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
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
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	cb306cdf-bab5-4b13-986b-21ade4764f00	2026-02-12	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	886c594f-4ff6-46e1-a992-cc6ec033db3a	2026-01-27	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11673-269-06	11673026906	160 BLISTER PACK in 1 CARTON (11673-269-06) > 1 GUM, CHEWING in 1 BLISTER PACK	160 blister pack	2019-03-14	0000-00-00	No	No	Current
11673-269-78	11673026978	100 BLISTER PACK in 1 CARTON (11673-269-78) > 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2019-03-14	0000-00-00	No	No	Current