Berkley and Jensen NICOTINE

Product NDC: 68391-012
Requested package NDC: 68391-012-29
11-digit product format: 683910012
Labeler code: 68391
Product ID: 68391-012_929ade4f-1d64-49e8-8d1f-5704aa5150f6
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: BJWC
Application: ANDA206394
Marketing category: ANDA
Marketing start: 2017-02-28
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68391-012	68391-012-29	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206394-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Berkley and Jensen NICOTINE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6M3C89ZY6R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314119	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cdaa2643-7630-41e8-bd48-4a760cf4a46a	Available on FDA.report

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
68391-012-25	Berkley and Jensen NICOTINE	110 in 1 CARTON	GUM, CHEWING	110	6
68391-012-25	Berkley and Jensen NICOTINE	1 in 1 BLISTER PACK	GUM, CHEWING	1	6
68391-012-29	Berkley and Jensen NICOTINE	2 in 1 CARTON	GUM, CHEWING	2	6
68391-012-29	Berkley and Jensen NICOTINE	110 in 1 CARTON	GUM, CHEWING	110	6
68391-012-70	Berkley and Jensen NICOTINE	2 in 1 PACKAGE	GUM, CHEWING	2	6
68391-012-76	Berkley and Jensen NICOTINE	1 in 1 BLISTER PACK	GUM, CHEWING	1	6
68391-012-76	Berkley and Jensen NICOTINE	120 in 1 CARTON	GUM, CHEWING	120	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68391-012	BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]	6	Current NDC, Legacy NDC, 7 package rows	20250410_cdaa2643-7630-41e8-bd48-4a760cf4a46a.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 3 · 41 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	2eca67db-1b7c-43dd-91af-4060e9b8e9d3	2026-07-15	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
Kirkland Signature Quit 2	NICOTINE POLACRILEX	Costco Wholesale Company	17f17eb6-ebc3-4a71-9f1b-41e2b5dcf6c1	2026-07-14	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
coated nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	97b06ada-b8b8-49fc-bc65-c3e835ef149b	2026-07-13	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	61c69497-91f9-45bf-ad48-33ac73e63a75	2026-07-10	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
topcare nicotine	NICOTINE POLACRILEX	Topco Associates LLC	c3c52b83-fdbe-4999-b982-37c63462eb7c	2026-06-30	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	f0f79275-c27a-4d35-a79a-53b0905c3761	2026-06-29	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
nicotine	NICOTINE POLACRILEX	H E B	a1f36614-539f-45db-aad4-1b300c60bf43	2026-06-26	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	060ef0cb-52ef-47b1-bcba-856e443d18a9	2026-06-26	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
Nicotine	NICOTINE POLACRILEX	Kroger Company	7295628f-3a9c-4e64-855b-0511aba64175	2026-06-25	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
HEB Nicotine	NICOTINE POLACRILEX	H E B	9e74cde3-4819-4868-b47e-fe6d1362fa59	2026-06-25	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
Basic Care Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	949d429c-3af3-4512-b742-2bfbf4701c34	2026-06-25	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	6627f4e3-1c62-43af-be58-df67f7a2dcaa	2026-06-25	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
nicotine	NICOTINE POLACRILEX	Kroger Company	3621f5df-f036-4d9f-9972-40e47912d713	2026-06-25	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
Foster and Thrive Nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	f2d0bf82-3cc7-4b06-9f2d-0c927416f6cf	2026-06-24	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
signature care nicotine	NICOTINE POLACRILEX	Safeway	a2c00ec8-3762-4594-a1dd-0b5add001d39	2026-06-19	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
careone nicotine	NICOTINE POLACRILEX	American Sales Company	21ae0d43-b78d-4f7e-90f1-01479454fc6b	2026-06-19	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394
Berkley and Jensen NICOTINE	NICOTINE POLACRILEX	BJWC	cdaa2643-7630-41e8-bd48-4a760cf4a46a	2026-06-19	Warnings	Exact identifier application applno (ANDA): 206394 application number: ANDA206394 ndc (package): 68391-012-29 ndc (product): 68391-012 ndc11 (package): 68391001229
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

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	cdaa2643-7630-41e8-bd48-4a760cf4a46a	6
314119	nicotine 2 MG Chewing Gum	SCD	cdaa2643-7630-41e8-bd48-4a760cf4a46a	6
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	cdaa2643-7630-41e8-bd48-4a760cf4a46a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68391-012-29	68391001229	2 CARTON in 1 CARTON (68391-012-29) > 110 BLISTER PACK in 1 CARTON > 1 GUM, CHEWING in 1 BLISTER PACK	2 carton	2017-02-28	0000-00-00	No	No	Current