Berkley and Jensen Nicotine

Product NDC: 68391-309
Requested package NDC: 68391-309-29
11-digit product format: 683910309
Labeler code: 68391
Product ID: 68391-309_ecc73ee8-3d06-4daf-b93b-4d180cc6bc68
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: BJWC
Application: ANDA206393
Marketing category: ANDA
Marketing start: 2017-02-28
Substance: NICOTINE
Active strength: 4 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	68391-309	68391-309-29	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
A206393-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG 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	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206393-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2016-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206393-001	NICOTINE POLACRILEX	EQ 4MG 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	4 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
311975	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
b04f4f1e-55d3-4486-acf1-6a93dc919f2d	Available on FDA.report

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
68391-309-25	Berkley and Jensen Nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1	7
68391-309-25	Berkley and Jensen Nicotine	110 in 1 CARTON	GUM, CHEWING	110	7
68391-309-29	Berkley and Jensen Nicotine	2 in 1 CARTON	GUM, CHEWING	2	7
68391-309-29	Berkley and Jensen Nicotine	110 in 1 CARTON	GUM, CHEWING	110	7
68391-309-70	Berkley and Jensen Nicotine	120 in 1 CARTON	GUM, CHEWING	120	7
68391-309-70	Berkley and Jensen Nicotine	2 in 1 CARTON	GUM, CHEWING	2	7
68391-309-76	Berkley and Jensen Nicotine	120 in 1 CARTON	GUM, CHEWING	120	7
68391-309-76	Berkley and Jensen Nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68391-309	BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC]	6	Current NDC, Legacy NDC, 8 package rows	20250315_b04f4f1e-55d3-4486-acf1-6a93dc919f2d.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 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	4ddba70a-3f45-4c76-a12a-6da256e9afc5	2026-07-23	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	c6c9582c-004d-4925-b147-add5f28f3856	2026-07-23	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	da4c5203-76d7-454f-85bd-1717d95506bd	2026-07-20	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
kirkland signature quit 4	NICOTINE POLACRILEX	Costco Wholesale Company	bfdf3918-3116-4351-b0a8-4c515e2e1f41	2026-07-14	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	03d9708a-923c-4fd3-ac3d-6ab4a4d8a804	2026-06-30	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
nicotine	NICOTINE POLACRILEX	H E B	9bf10dfc-c6df-4cc9-ba79-2dcf874a2904	2026-06-26	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
nicotine	NICOTINE POLACRILEX	H E B	55defc7f-f91d-46eb-8558-2ab1b69ec6a1	2026-06-26	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	44cce141-dd0e-47ba-b7fe-7cd6f7935ba5	2026-06-26	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
Nicotine	NICOTINE POLACRILEX	Kroger Company	1d55fe3e-9c41-409f-8b1d-3c02688903e9	2026-06-25	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
nicotine	NICOTINE POLACRILEX	Kroger Company	37ad9304-7a00-4ec0-bbbb-cf133e0e8bc8	2026-06-25	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	860f8306-4cd4-4444-8c6e-182ddeb10ad6	2026-06-25	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
Basic Care Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	bbeb84ae-c98f-422e-9770-e44961af593f	2026-06-25	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
nicotine	NICOTINE	H E B	bfe954a2-c078-4a63-a3bb-f9ef7d8806f7	2026-06-25	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	9a1c3e96-9a12-448b-a732-e4eb277327f7	2026-06-25	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
signature care nicotine	NICOTINE POLACRILEX	Safeway	bcf4407a-b0ff-40bb-9bb9-6c36bdd525fc	2026-06-19	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
signature care nicotine	NICOTINE POLACRILEX	Safeway	1a5508fb-14b7-4ede-a238-6e328ae706da	2026-06-19	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
careone nicotine	NICOTINE POLACRILEX	American Sales Company	be90d633-e928-484c-9fa7-d363c23bb89c	2026-06-19	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
Berkley and Jensen Nicotine	NICOTINE POLACRILEX	BJWC	b04f4f1e-55d3-4486-acf1-6a93dc919f2d	2026-06-19	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393 ndc (package): 68391-309-29 ndc (product): 68391-309 ndc11 (package): 68391030929
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	107d6b24-fa5e-4fff-8365-b0b92251708e	2026-06-18	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393
COATED NICOTINE	NICOTINE POLACRILEX	Publix Super Markets Inc	8868a487-d77b-4c6f-8ef9-5a6fe22ce0ad	2026-06-18	Warnings	Exact identifier application applno (ANDA): 206393 application number: ANDA206393

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	b04f4f1e-55d3-4486-acf1-6a93dc919f2d	7
311975	nicotine 4 MG Chewing Gum	SCD	b04f4f1e-55d3-4486-acf1-6a93dc919f2d	7
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	b04f4f1e-55d3-4486-acf1-6a93dc919f2d	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68391-309-29	68391030929	2 CARTON in 1 CARTON (68391-309-29) > 110 BLISTER PACK in 1 CARTON > 1 GUM, CHEWING in 1 BLISTER PACK	2 carton	2017-02-28	0000-00-00	No	No	Current