Care One Nicotine

Product NDC: 41520-854
11-digit product format: 415200854
Labeler code: 41520
Product ID: 41520-854_e82e1e11-e72f-493e-8863-b1347b301008
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: American Sales Company
Application: ANDA078546
Marketing category: ANDA
Marketing start: 2008-07-25
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

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
A078546-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2007-05-24

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	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078546-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Care One 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
78cf8b14-cdad-464c-afb5-9fc49ebc3921	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
41520-854-78	Care One Nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1		8
41520-854-78	Care One Nicotine	100 in 1 CARTON	GUM, CHEWING	100		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-854	CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]	8	Current NDC, Legacy NDC, 2 package rows	20250331_78cf8b14-cdad-464c-afb5-9fc49ebc3921.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	b8cbb6a7-aeb4-48f3-a0ed-7ad803021752	2026-06-26	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	59ba5cba-be1e-4708-a9ab-01f43543bb5b	2026-06-19	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
Care One Nicotine	NICOTINE POLACRILEX	American Sales Company	78cf8b14-cdad-464c-afb5-9fc49ebc3921	2026-06-19	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546 ndc (product): 41520-854
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	426e7bbc-cf58-4be0-a8e5-30a8f7ca5b48	2026-05-20	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	0f1b3cc6-98df-4e34-91f3-dc251fe170f8	2026-04-28	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546
Equate Nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	54c1a1d5-f7b4-4109-8887-02dc10bfd593	2025-09-16	Warnings	Exact identifier application applno (ANDA): 078546 application number: ANDA078546

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	78cf8b14-cdad-464c-afb5-9fc49ebc3921	8
311975	nicotine 4 MG Chewing Gum	SCD	78cf8b14-cdad-464c-afb5-9fc49ebc3921	8
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	78cf8b14-cdad-464c-afb5-9fc49ebc3921	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-854-78	41520085478	100 BLISTER PACK in 1 CARTON (41520-854-78) / 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2008-07-25	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	2026-06-19	HUMAN OTC DRUG LABEL	9