Up and Up Nicotine

Product NDC: 11673-344
11-digit product format: 116730344
Labeler code: 11673
Product ID: 11673-344_0614d4a9-e3e8-449f-bc39-91c58e77026d
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Target Corporation
Application: ANDA077007
Marketing category: ANDA
Marketing start: 2009-06-16
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	11673-344		D	Discontinued by firm	2026-10-12
excluded package	package	11673-344	11673-344-03	D	Discontinued by firm	2026-10-12
excluded package	package	11673-344	11673-344-05	D	Discontinued by firm	2026-10-12
excluded package	package	11673-344	11673-344-06	D	Discontinued by firm	2026-10-12
excluded package	package	11673-344	11673-344-14	D	Discontinued by firm	2026-10-12
excluded package	package	11673-344	11673-344-16	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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	11673-344-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	11673-344-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	11673-344-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	11673-344-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	11673-344-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	11673-344-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	11673-344-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	11673-344-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	11673-344-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	11673-344-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	11673-344-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	11673-344-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	11673-344-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	11673-344-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	11673-344-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	11673-344-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	11673-344-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	11673-344-06	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	11673-344-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	11673-344-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	11673-344-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	11673-344-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	11673-344-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	11673-344-06	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11673-344-05	EA - Each	11673-344	b18f6207-b101-463a-9013-0059b0c0cdf8	1	2016-05-16
11673-344-16	EA - Each	11673-344	183910eb-d904-455b-a631-31320528d2a4	1	2016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	UP AND UP NICOTINE (NICOTINE POLACRILEX) LOZENGE [TARGET CORPORATION]	4
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	UP AND UP NICOTINE (NICOTINE POLACRILEX) LOZENGE [TARGET CORPORATION]	4
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	UP AND UP NICOTINE (NICOTINE POLACRILEX) LOZENGE [TARGET CORPORATION]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	UP AND UP NICOTINE (NICOTINE POLACRILEX) LOZENGE [TARGET CORPORATION]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	UP AND UP NICOTINE (NICOTINE POLACRILEX) LOZENGE [TARGET CORPORATION]	4
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	UP AND UP NICOTINE (NICOTINE POLACRILEX) LOZENGE [TARGET CORPORATION]	4
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	UP AND UP NICOTINE (NICOTINE POLACRILEX) LOZENGE [TARGET CORPORATION]	4
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	UP AND UP NICOTINE (NICOTINE POLACRILEX) LOZENGE [TARGET CORPORATION]	4
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	UP AND UP NICOTINE (NICOTINE POLACRILEX) LOZENGE [TARGET CORPORATION]	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	UP AND UP NICOTINE (NICOTINE POLACRILEX) LOZENGE [TARGET CORPORATION]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11673-344	UP AND UP NICOTINE (NICOTINE POLACRILEX) LOZENGE [TARGET CORPORATION]	9	Legacy NDC	20210225_557898e7-097b-412e-bbc6-908a3d8df517.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 5 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
exchange select nicotine	NICOTINE POLACRILEX	Army & Air Force Exchange Service	c1f1048b-e581-45bf-b344-8e2b0b7488bb	2021-05-27	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11673-344-03	11673034403	1 CONTAINER in 1 CARTON (11673-344-03) > 24 LOZENGE in 1 CONTAINER	1 container	2017-08-31	0000-00-00	No	No	Current
11673-344-05	11673034405	3 CONTAINER in 1 CARTON (11673-344-05) > 24 LOZENGE in 1 CONTAINER	3 container	2009-12-30	0000-00-00	No	No	Current
11673-344-14	11673034414	8 CONTAINER in 1 CARTON (11673-344-14) > 27 LOZENGE in 1 CONTAINER	8 container	2016-03-17	0000-00-00	No	No	Current
11673-344-16	11673034416	6 CONTAINER in 1 CARTON (11673-344-16) > 24 LOZENGE in 1 CONTAINER	6 container	2010-03-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Target Corporation Nicotine Polacrilex Lozenge 2 mg (Nicotine) Drug Facts	Target Corporation	2021-02-17	HUMAN OTC DRUG LABEL	9