Up and Up Nicotine Polacrilex

Product NDC: 11673-442
Requested package NDC: 11673-442-78
11-digit product format: 116730442
Labeler code: 11673
Product ID: 11673-442_bf0c3842-c4d9-4f34-a425-17ed6832345a
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Target Corporation
Application: ANDA091354
Marketing category: ANDA
Marketing start: 2013-08-09
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 4 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	11673-442	11673-442-78	D	Discontinued by firm		2026-08-10

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
A091354-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2011-07-20

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	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091354-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2011-07-20	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11673-442-78	EA - Each	11673-442	5b1a5f0b-7ec5-458e-a673-79198799cd92	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11673-442	UP AND UP NICOTINE POLACRILEX (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION]	7	Legacy NDC	20210413_7773c8f8-cf6a-4649-a649-7e2c89903560.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 1 · 2 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	174c342d-898e-4d16-a688-5184a1ae409f	2026-06-30	Warnings	Exact identifier application applno (ANDA): 091354 application number: ANDA091354
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	aff57914-5af5-46b6-8f80-9db518750843	2026-06-24	Warnings	Exact identifier application applno (ANDA): 091354 application number: ANDA091354

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
11673-442-78	11673044278	100 BLISTER PACK in 1 CARTON (11673-442-78) > 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2013-08-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Target Corporation Nicotine Gum 4mg Drug Facts	Target Corporation	2021-04-12	HUMAN OTC DRUG LABEL	7