NICOTINE

Product NDC: 58602-903
11-digit product format: 586020903
Labeler code: 58602
Product ID: 58602-903_dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa
Type: HUMAN OTC DRUG
Nonproprietary name: NICOTINE POLACRILEX
Dosage form: LOZENGE
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA213266
Marketing category: ANDA
Marketing start: 2022-06-24
Substance: NICOTINE
Active strength: 2 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 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
A213266-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2021-08-03
A213266-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2021-08-03

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 · 70 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	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213266-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213266-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2021-08-03	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: NICOTINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	2 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
359817	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
dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa	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
58602-903-07	NICOTINE	1 in 1 CARTON	LOZENGE	1	1
58602-903-07	NICOTINE	24 in 1 CONTAINER	LOZENGE	24	1
58602-903-51	NICOTINE	24 in 1 CONTAINER	LOZENGE	24	1
58602-903-51	NICOTINE	3 in 1 CARTON	LOZENGE	3	1
58602-903-65	NICOTINE	24 in 1 CONTAINER	LOZENGE	24	1
58602-903-65	NICOTINE	6 in 1 CARTON	LOZENGE	6	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-903	NICOTINE (NICOTINE POLACRILEX) LOZENGE [AUROHEALTH LLC]	1	Current NDC, Legacy NDC, 6 package rows	20220626_dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa.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	Aurohealth LLC	cbf094d4-2357-426d-8205-9b59c332854f	2026-06-16	Warnings	Exact identifier application applno (ANDA): 213266 application number: ANDA213266
NICOTINE	NICOTINE POLACRILEX	Aurohealth LLC	56a1c778-fc3b-4848-a7e0-b1e4f0a8fbc2	2026-06-12	Warnings	Exact identifier application applno (ANDA): 213266 application number: ANDA213266
AMAZON BASIC CARE NICOTINE POLACRILEX	NICOTINE POLACRILEX	Amazon.com Services LLC	113e0be9-7edc-4766-e063-6294a90af752	2025-05-02	Warnings	Exact identifier application applno (ANDA): 213266 application number: ANDA213266
AMAZON BASIC CARE NICOTINE POLACRILEX	NICOTINE POLACRILEX	Amazon.com Services LLC	10ece1fa-f4c2-42ad-e063-6394a90a3a7d	2025-05-02	Warnings	Exact identifier application applno (ANDA): 213266 application number: ANDA213266
NICOTINE	NICOTINE POLACRILEX	Aurohealth LLC	810932e0-a982-400a-b43d-b847152f685b	2022-06-24	Warnings	Exact identifier application applno (ANDA): 213266 application number: ANDA213266
NICOTINE	NICOTINE POLACRILEX	Aurohealth LLC	dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa	2022-06-24	Warnings	Exact identifier application applno (ANDA): 213266 application number: ANDA213266 ndc (product): 58602-903
NICOTINE	NICOTINE POLACRILEX	Aurohealth LLC	1909cf25-bce8-4880-abc6-548d28a7285d	2022-03-07	Warnings	Exact identifier application applno (ANDA): 213266 application number: ANDA213266
NICOTINE	NICOTINE POLACRILEX	Aurohealth LLC	fa730ae3-c2b3-4ea4-8e50-f819b205d168	2022-03-07	Warnings	Exact identifier application applno (ANDA): 213266 application number: ANDA213266

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
359817	nicotine 2 MG Oral Lozenge	PSN	dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa	1
359817	nicotine 2 MG Oral Lozenge	SCD	dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa	1
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa	1
359817	nicotine 2 MG Troche	SY	dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-903-07	58602090307	1 CONTAINER in 1 CARTON (58602-903-07) / 24 LOZENGE in 1 CONTAINER	1 container	2022-06-24	0000-00-00	No	No	Current
58602-903-51	58602090351	3 CONTAINER in 1 CARTON (58602-903-51) / 24 LOZENGE in 1 CONTAINER	3 container	2022-06-24	0000-00-00	No	No	Current
58602-903-65	58602090365	6 CONTAINER in 1 CARTON (58602-903-65) / 24 LOZENGE in 1 CONTAINER	6 container	2022-06-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NICOTINE - Aurohealth LLC \| APL HEALTHCARE LIMITED	Aurohealth LLC \| APL HEALTHCARE LIMITED	2022-06-24	Human OTC Drug Label	1