nicotine

Product NDC: 41250-422
Requested package NDC: 41250-422-29
11-digit product format: 412500422
Labeler code: 41250
Product ID: 41250-422_6ac5444c-199a-49ca-bcde-585f38e73fcf
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Meijer Distribution Inc
Application: ANDA078326
Marketing category: ANDA
Marketing start: 2005-01-24
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	41250-422	41250-422-29	D	Discontinued by firm		2026-09-14

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
A078326-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2006-10-30

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	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078326-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

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	SPL version
41250-422-25	nicotinemint flavor	110 in 1 CARTON	GUM, CHEWING	110	6
41250-422-25	nicotinemint flavor	1 in 1 BLISTER PACK	GUM, CHEWING	1	6
41250-422-29	nicotinemint flavor	1 in 1 BLISTER PACK	GUM, CHEWING	1	6
41250-422-29	nicotinemint flavor	220 in 1 CARTON	GUM, CHEWING	220	6
41250-422-96	nicotinemint flavor	170 in 1 CARTON	GUM, CHEWING	170	6
41250-422-96	nicotinemint flavor	1 in 1 BLISTER PACK	GUM, CHEWING	1	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-422	NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	6	Legacy NDC, 6 package rows	20210409_fc38e37e-cfab-46e8-9ead-b56c193b4d42.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	768e3f3d-d867-4574-8a5d-07572e2e4a04	2026-06-29	Warnings	Exact identifier application applno (ANDA): 078326 application number: ANDA078326
GOOD SENSE	NICOTINE POLACRILEX	A-S Medication Solutions	dece0a8d-a7df-446f-bfcf-9f96e8bfc4ae	2023-10-31	Warnings	Exact identifier application applno (ANDA): 078326 application number: ANDA078326

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
311975	nicotine polacrilex 4 MG Chewing Gum	PSN	fc38e37e-cfab-46e8-9ead-b56c193b4d42	6
311975	nicotine 4 MG Chewing Gum	SCD	fc38e37e-cfab-46e8-9ead-b56c193b4d42	6
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	fc38e37e-cfab-46e8-9ead-b56c193b4d42	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-422-29	41250042229	220 BLISTER PACK in 1 CARTON (41250-422-29) > 1 GUM, CHEWING in 1 BLISTER PACK	220 blister pack	2011-06-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Nicotine Gum Drug Facts	Meijer Distribution Inc	2021-04-08	HUMAN OTC DRUG LABEL	6