NICOTINE

Product NDC: 58602-723
11-digit product format: 586020723
Labeler code: 58602
Product ID: 58602-723_85f05cc6-ae2e-4338-8c1e-c681c2f90858
Type: HUMAN OTC DRUG
Nonproprietary name: NICOTINE POLACRILEX MINI
Dosage form: LOZENGE
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA215357
Marketing category: ANDA
Marketing start: 2022-11-03
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 42.

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
A215357-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2022-05-13
A215357-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2022-05-13

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 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215357-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215357-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2022-05-13	`a72a2bbeb626…`

Additional Listing Data#

Finished product: Yes
Brand name base: 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
85f05cc6-ae2e-4338-8c1e-c681c2f90858	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
58602-723-81	NICOTINE	27 in 1 CONTAINER	LOZENGE	27	1
58602-723-81	NICOTINE	4 in 1 CARTON	LOZENGE	4	1
58602-723-84	NICOTINE	3 in 1 CARTON	LOZENGE	3	1
58602-723-84	NICOTINE	27 in 1 CONTAINER	LOZENGE	27	1
58602-723-85	NICOTINE	27 in 1 CONTAINER	LOZENGE	27	1
58602-723-85	NICOTINE	5 in 1 CARTON	LOZENGE	5	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-723	NICOTINE (NICOTINE POLACRILEX MINI) LOZENGE [AUROHEALTH LLC]	1	Current NDC, Legacy NDC, 6 package rows	20221104_85f05cc6-ae2e-4338-8c1e-c681c2f90858.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NICOTINE	NICOTINE POLACRILEX MINI	Aurohealth LLC	5102e242-4d27-4b1f-8a65-2b52ba3f2276	2025-05-14	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357
AMAZON BASIC CARE NICOTINE POLACRILEX	NICOTINE POLACRILEX MINI	Amazon.com Services LLC	113e54e3-e9c3-4949-e063-6394a90a6fdf	2025-05-02	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357
AMAZON BASIC CARE NICOTINE POLACRILEX	NICOTINE POLACRILEX MINI	Amazon.com Services LLC	10ee6816-8155-d590-e063-6394a90a9dea	2025-05-02	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357
NICOTINE	NICOTINE POLACRILEX MINI	Aurohealth LLC	169c7976-f865-4716-953d-383e435d67c5	2024-06-20	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357
NICOTINE	NICOTINE POLACRILEX MINI	BLIP PRODUCTS, INC.	e88c8815-4d38-3a59-e053-2995a90afc82	2023-08-11	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357
NICOTINE	NICOTINE POLACRILEX MINI	BLIP PRODUCTS, INC.	eb714022-332d-5c6f-e053-2a95a90a75c9	2023-08-11	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357
NICOTINE	NICOTINE POLACRILEX MINI	Aurohealth LLC	85f05cc6-ae2e-4338-8c1e-c681c2f90858	2022-11-03	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357 ndc (product): 58602-723
NICOTINE	NICOTINE POLACRILEX MINI	Aurohealth LLC	cfe6fb63-2897-4e76-8288-1389f363b3c4	2022-11-03	Warnings	Exact identifier application applno (ANDA): 215357 application number: ANDA215357

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	85f05cc6-ae2e-4338-8c1e-c681c2f90858	1
359818	nicotine 4 MG Oral Lozenge	SCD	85f05cc6-ae2e-4338-8c1e-c681c2f90858	1
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	85f05cc6-ae2e-4338-8c1e-c681c2f90858	1
359818	nicotine 4 MG Troche	SY	85f05cc6-ae2e-4338-8c1e-c681c2f90858	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-723-81	58602072381	4 CONTAINER in 1 CARTON (58602-723-81) / 27 LOZENGE in 1 CONTAINER	4 container	2022-11-03	0000-00-00	No	No	Current
58602-723-84	58602072384	3 CONTAINER in 1 CARTON (58602-723-84) / 27 LOZENGE in 1 CONTAINER	3 container	2022-11-03	0000-00-00	No	No	Current
58602-723-85	58602072385	5 CONTAINER in 1 CARTON (58602-723-85) / 27 LOZENGE in 1 CONTAINER	5 container	2022-11-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotine Polacrilex Lozenge	Aurohealth LLC \| APL HEALTHCARE LIMITED	2022-11-03	Human OTC Drug Label	1