nicotine

Product NDC: 69842-828
11-digit product format: 698420828
Labeler code: 69842
Product ID: 69842-828_b68e7fd1-5a91-4620-bfcd-23115a927fba
Type: HUMAN OTC DRUG
Nonproprietary name: nicotine
Dosage form: LOZENGE
Route: ORAL
Labeler: CVS Pharmacy
Application: ANDA203690
Marketing category: ANDA
Marketing start: 2020-02-04
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

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	69842-828	69842-828-07	D	Discontinued by firm		2026-10-15

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69842-828	69842-828-07	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`c2088c7a36db…`
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…`

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: nicotine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	4 mg/1

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
69842-828-07	nicotine	27 in 1 CONTAINER	LOZENGE	27	3
69842-828-07	nicotine	3 in 1 CARTON	LOZENGE	3	3
69842-828-60	nicotine	20 in 1 CONTAINER	LOZENGE	20	3
69842-828-60	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
69842-828	NICOTINE LOZENGE [CVS PHARMACY]	2	Current NDC, Legacy NDC, 4 package rows	20200414_efa1059d-85d0-4af2-9980-cc19b11f408b.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 5 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
signature care nicotine	NICOTINE POLACRILEX	Safeway	664c3faf-7cab-4bda-8987-07acb8e1142b	2018-10-31	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
exchange select nicotine	NICOTINE POLACRILEX	Army & Air Force Exchange Service	e926cf6f-305a-4912-be07-a45bb7905822	2018-09-21	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
berkley and jensen nicotine	NICOTINE POLACRILEX	BJWC	357123fc-0972-4683-ab52-f95d46c1b6c9	2017-11-09	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	efa1059d-85d0-4af2-9980-cc19b11f408b	3
359818	nicotine 4 MG Oral Lozenge	SCD	efa1059d-85d0-4af2-9980-cc19b11f408b	3
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	efa1059d-85d0-4af2-9980-cc19b11f408b	3
359818	nicotine 4 MG Troche	SY	efa1059d-85d0-4af2-9980-cc19b11f408b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-828-07	69842082807	3 CONTAINER in 1 CARTON (69842-828-07) > 27 LOZENGE in 1 CONTAINER	3 container	2020-02-05	0000-00-00	No	No	Current
69842-828-60	69842082860	1 CONTAINER in 1 CARTON (69842-828-60) / 20 LOZENGE in 1 CONTAINER	1 container	2020-02-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Pharmacy, Inc. Nicotine Lozenge Drug Facts	CVS Pharmacy \| L. Perrigo Company	2026-09-22	HUMAN OTC DRUG LABEL	4