basic care nicotine

Product NDC: 72288-642
11-digit product format: 722880642
Labeler code: 72288
Product ID: 72288-642_c67d132b-ef81-458f-aa04-caa01da36fbf
Type: HUMAN OTC DRUG
Nonproprietary name: nicotine polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Amazon.com Services LLC
Application: ANDA203690
Marketing category: ANDA
Marketing start: 2021-04-29
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	72288-642	72288-642-60	D	Discontinued by firm		2026-10-12

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203690-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2012-10-09
A203690-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2012-10-09

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: basic care nicotine
Listing expiration: 2026-12-31

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
359818	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
f3035ca0-8739-4d77-af97-f6021d6478c2	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
72288-642-07	basic care nicotine	3 in 1 CARTON	LOZENGE	3	3
72288-642-09	basic care nicotine	27 in 1 CONTAINER	LOZENGE	27	3
72288-642-60	basic care nicotine	20 in 1 CONTAINER	LOZENGE	20	3
72288-642-60	basic care nicotine	1 in 1 CARTON	LOZENGE	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72288-642	BASIC CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMAZON.COM SERVICES LLC]	2	Current NDC, Legacy NDC, 4 package rows	20220624_f3035ca0-8739-4d77-af97-f6021d6478c2.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 2 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CareOne Nicotine	NICOTINE POLACRILEX	American Sales Company	74ec6a60-eb3a-47d4-a11b-650b6418d37f	2026-04-14	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
up and up cherry ice nicotine	NICOTINE POLACRILEX	Target Corporation	99977d30-41ba-4237-920a-dbd5ad8fc380	2026-04-14	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
Nicotine	NICOTINE POLACRILEX	CVS Pharmacy	65ceb67b-dc22-4f5f-bfce-d6e957835eb3	2026-04-13	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	1a7cfbdc-53cc-4cd2-86b2-6e27a7979abf	2026-04-08	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
good sense nicotine	NICOTINE POLACRILEX	L. Perrigo Company	1e2631b6-b99e-4345-840e-9ddd0873a421	2026-04-07	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
up and up mint mini nicotine	NICOTINE POLACRILEX	Target Corporation	b07f00fe-84da-4d1c-a57f-6579b9f3fb9d	2026-03-17	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
up and up nicotine mini mint	NICOTINE POLACRILEX	Target Corporation	43f9d241-3af1-46cb-abe9-8c25427472aa	2026-03-17	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
Up and Up Mini Nicotine	NICOTINE POLACRILEX	Target Corporation	a15b247e-cf4f-4802-a6e4-24750ea3809b	2026-03-17	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
nicotine	NICOTINE POLACRILEX	H E B	b1a13942-1fad-40da-8664-f70574b950d7	2026-03-11	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
Nicotine	NICOTINE	H E B	85e3a322-e1a2-4f8e-a616-b279ad1bcefe	2026-03-03	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
Nicotine	NICOTINE	H E B	be4a13e4-9938-4223-bcc1-4f5d96972813	2026-03-03	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
nicotine	NICOTINE POLACRILEX	H E B	1fb02f5e-56af-47ef-a1bc-49a6d86cc70c	2026-03-03	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
BLIP	NICOTINE POLACRILEX	Blip Products, Inc.	291649cf-e5a6-4a98-9a9e-c499b55c37ae	2026-03-02	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
nicotine	NICOTINE POLACRILEX	Kroger Company	fd67cb75-509c-41d5-8a2c-6c5fc53bf513	2026-02-26	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
Nicotine Mini	NICOTINE POLACRILEX	Kroger Company	965be729-d417-4ae6-a2a9-ed06c2287d42	2026-02-17	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	9f2f06c3-4d9b-4c1a-85e3-26f021be5d7c	2026-02-16	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	17cf8f3d-6491-4cd8-a447-3c7533f76daf	2026-02-13	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
Nicotine Mini	NICOTINE POLACRILEX	Kroger Company	756c6b45-704e-4684-96ba-4df3ef27552c	2026-02-12	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
mini nicotine	NICOTINE POLACRILEX	Meijer, Inc.	7354774e-6784-48cb-84aa-57bcc17828c0	2026-02-10	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
members mark mini nicotine	NICOTINE POLACRILEX	Sam's West Inc	5d05f906-8447-43a1-9460-c6da3f3873c7	2026-02-06	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690

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
359818	nicotine 4 MG Oral Lozenge	PSN	f3035ca0-8739-4d77-af97-f6021d6478c2	3
359818	nicotine 4 MG Oral Lozenge	SCD	f3035ca0-8739-4d77-af97-f6021d6478c2	3
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	f3035ca0-8739-4d77-af97-f6021d6478c2	3
359818	nicotine 4 MG Troche	SY	f3035ca0-8739-4d77-af97-f6021d6478c2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72288-642-07	72288064207	3 CONTAINER in 1 CARTON (72288-642-07) / 27 LOZENGE in 1 CONTAINER (72288-642-09)	3 container	2021-04-29	0000-00-00	No	No	Current
72288-642-09	72288064209	27 LOZENGE in 1 CONTAINER (72288-642-09)	27 lozenge	2022-05-05	0000-00-00	No	No	Current
72288-642-60	72288064260	1 CONTAINER in 1 CARTON (72288-642-60) > 20 LOZENGE in 1 CONTAINER	1 container	2022-05-05	0000-00-00	No	No	Current