careone nicotine

Product NDC: 41520-891
11-digit product format: 415200891
Labeler code: 41520
Product ID: 41520-891_234ba6b8-1f92-4b23-aa8a-726af142f030
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: American Sales Company
Application: ANDA076789
Marketing category: ANDA
Marketing start: 2017-11-13
Substance: NICOTINE
Active strength: 4 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A076789-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2004-09-16

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	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: careone 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
97926c62-b56a-4ce0-addb-037d90d297e7	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	Strength	SPL version
41520-891-25	careone nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1		4
41520-891-25	careone nicotine	110 in 1 CARTON	GUM, CHEWING	110		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-891	CAREONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3	Current NDC, Legacy NDC, 2 package rows	20250523_97926c62-b56a-4ce0-addb-037d90d297e7.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 · 15 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	ecdfe02c-813b-4c1e-9e02-d7c544a89644	2026-07-23	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
kirkland signature quit 4	NICOTINE POLACRILEX	Costco Wholesale Company	b9dd4e89-0023-4552-bdd6-1c046ce3bd87	2026-07-14	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	ae802de5-8e1b-439f-ab81-db4bd7241c91	2026-07-10	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
signature care nicotine	NICOTINE POLACRILEX	Safeway	3591828f-dff0-4cb7-ab0e-d43704243dc2	2026-06-12	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
nicotine	NICOTINE POLACRILEX	H E B	bbc4fd9f-b1f5-4691-b980-3424c91e4c88	2026-06-12	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
members mark nicotine	NICOTINE POLACRILEX	Sam's West Inc	8edad777-6491-4ab2-9835-709bf54d5f0c	2026-06-11	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	dc6b806a-f571-4d33-9b93-3dcd21ad0260	2026-06-09	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	63ac801f-02ed-43a1-a2a8-2ad35d8fd7a9	2026-06-09	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	1c49ddd3-0f2c-4310-acf1-edd42e3aafc5	2026-04-28	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
up and up uncoated original nicotine	NICOTINE POLACRILEX	Target Corporation	f837023e-29e1-49c5-89af-b491e8302fd9	2026-04-18	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
careone nicotine	NICOTINE POLACRILEX	American Sales Company	97926c62-b56a-4ce0-addb-037d90d297e7	2026-04-03	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789 ndc (product): 41520-891
Equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	0eb7bd68-7260-404c-a928-7898c6c26572	2026-02-23	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	1a916693-6092-4875-872a-7438816c0ddf	2026-02-12	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	d146d768-b975-462c-bc94-c2132e1bdac7	2023-08-28	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
berkley and jensen nicotine	NICOTINE POLACRILEX	BJWC	cf91dba6-f461-4370-920b-bc148089afe7	2021-04-02	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789

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	97926c62-b56a-4ce0-addb-037d90d297e7	4
311975	nicotine 4 MG Chewing Gum	SCD	97926c62-b56a-4ce0-addb-037d90d297e7	4
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	97926c62-b56a-4ce0-addb-037d90d297e7	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-891-25	41520089125	110 BLISTER PACK in 1 CARTON (41520-891-25) / 1 GUM, CHEWING in 1 BLISTER PACK	110 blister pack	2017-11-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company Nicotine Gum Drug Facts	American Sales Company	2026-04-03	HUMAN OTC DRUG LABEL	4