nicotine

Product NDC: 41250-206
11-digit product format: 412500206
Labeler code: 41250
Product ID: 41250-206_9c9aa278-5e64-4071-9eff-6bafb2d9d425
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Meijer Distribution Inc
Application: ANDA078325
Marketing category: ANDA
Marketing start: 2005-01-24
Substance: NICOTINE
Active strength: 2 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	41250-206		D	Discontinued by firm	2026-08-03
excluded package	package	41250-206	41250-206-25	D	Discontinued by firm	2026-08-03
excluded package	package	41250-206	41250-206-29	D	Discontinued by firm	2026-08-03
excluded package	package	41250-206	41250-206-96	D	Discontinued by firm	2026-08-03

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	41250-206-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	41250-206-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	41250-206-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	41250-206-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	41250-206-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	41250-206-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	41250-206-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	41250-206-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	41250-206-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	41250-206-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	41250-206-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	41250-206-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	41250-206-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	41250-206-96	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	41250-206-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	41250-206-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	41250-206-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	41250-206-96	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	41250-206-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	41250-206-96	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	41250-206-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	41250-206-96	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	41250-206-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	41250-206-96	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078325-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG 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 · 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	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078325-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2006-10-30	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
41250-206-25	nicotine	110 in 1 CARTON	GUM, CHEWING	110	7
41250-206-25	nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1	7
41250-206-29	nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1	7
41250-206-29	nicotine	220 in 1 CARTON	GUM, CHEWING	220	7
41250-206-96	nicotine	170 in 1 CARTON	GUM, CHEWING	170	7
41250-206-96	nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41250-206-29	EA - Each	41250-206	471d0018-2787-4b8a-b1fd-cf7025f57cd6	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NICOTINE (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
41250-206	NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]	7	Current NDC, Legacy NDC, 6 package rows	20231130_b2e7e90f-92df-4cd3-ba33-2565b3c2b7f4.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 · 1 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	049d2c75-9b7f-4248-81e9-e2973a4cab5d	2026-03-03	Warnings	Exact identifier application applno (ANDA): 078325 application number: ANDA078325

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	b2e7e90f-92df-4cd3-ba33-2565b3c2b7f4	7
314119	nicotine 2 MG Chewing Gum	SCD	b2e7e90f-92df-4cd3-ba33-2565b3c2b7f4	7
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	b2e7e90f-92df-4cd3-ba33-2565b3c2b7f4	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-206-25	41250020625	110 in 1 CARTON						Historical
41250-206-29	41250020629	220 BLISTER PACK in 1 CARTON (41250-206-29) / 1 GUM, CHEWING in 1 BLISTER PACK	220 blister pack	2011-06-03	0000-00-00	No	No	Current
41250-206-96	41250020696	170 BLISTER PACK in 1 CARTON (41250-206-96) > 1 GUM, CHEWING in 1 BLISTER PACK	170 blister pack	2005-01-24	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	2023-11-29	HUMAN OTC DRUG LABEL	7