Maxi Nicotine

Product NDC: 0536-1338
11-digit product format: 005361338
Labeler code: 0536
Product ID: 0536-1338_21f25fb4-08b3-4f4f-ad3f-3b8e0c6836f2
Type: HUMAN OTC DRUG
Nonproprietary name: nicotine polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Rugby Laboratories, Inc.
Application: ANDA209206
Marketing category: ANDA
Marketing start: 2021-09-17
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 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
A209206-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2018-06-26
A209206-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2018-06-26

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	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209206-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209206-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2018-06-26	`74a2ff9319b5…`

Additional Listing Data#

Finished product: Yes
Brand name base: Maxi 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
7c2e0872-75f6-4c4f-afff-3579375708de	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
0536-1338-09	Maxi Nicotine	3 in 1 BOX	LOZENGE	3	6
0536-1338-09	Maxi Nicotine	24 in 1 BOTTLE, PLASTIC	LOZENGE	24	6
0536-1338-35	Maxi Nicotine	24 in 1 BOTTLE, PLASTIC	LOZENGE	24	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1338-09	EA - Each	0536-1338	2f593a30-83f0-4a80-b412-4c2c5a8d09aa	1	2021-12-08
0536-1338-35	EA - Each	0536-1338	13e0900c-52d2-48de-8ef7-b6aa839d509f	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0536-1338	MAXI NICOTINE (NICOTINE POLACRILEX) LOZENGE [RUGBY LABORATORIES, INC.]	4	Current NDC, Legacy NDC, 3 package rows	20250112_7c2e0872-75f6-4c4f-afff-3579375708de.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	a33b6ed6-2c75-4bab-98e5-a7f8bea21926	2026-08-12	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206
Nicotine	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	39640129-2d7a-4ec5-81a1-e14b11d3d3ee	2026-03-12	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206
Nicotine	NICOTINE POLACRILEX	Walgreens	25dc2032-4e6a-440a-8327-7b6c877a2430	2026-01-20	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206
Nicotine	NICOTINE POLACRILEX	Walgreens	49a8e4f0-2b4c-4928-98f8-c8f9bb17c0f4	2026-01-20	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206
Nicotine Sugar Free	NICOTINE POLACRILEX	CVS Pharmacy	a275ff04-4078-4783-932b-dde9aee04682	2025-08-26	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206
Nicotine Sugar Free	NICOTINE POLACRILEX	CVS Pharmacy	63fce25d-457f-4048-86a4-1805f603936c	2025-08-26	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206
Maxi Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	1472b0a3-5ff1-44e7-8748-a3b1a5e55196	2025-08-25	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206
Nicotine	NICOTINE POLACRILEX	Rugby Laboratories, Inc.	150faf42-491f-403b-869b-48edd431d1cc	2025-07-18	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206
Maxi Nicotine	NICOTINE POLACRILEX	Rugby Laboratories, Inc.	7c2e0872-75f6-4c4f-afff-3579375708de	2025-07-18	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206 ndc (product): 0536-1338
Nicotine	NICOTINE POLACRILEX	Cardinal Health (Leader) 70000	80195d3b-9341-4354-8a65-b5b080b524d0	2025-02-26	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206
Maxi Nicotine	NICOTINE POLACRILEX	Cardinal Health (Leader) 70000	362b4a04-4a5f-4af6-9cd7-82aa172b7afb	2025-02-26	Warnings	Exact identifier application applno (ANDA): 209206 application number: ANDA209206

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	7c2e0872-75f6-4c4f-afff-3579375708de	6
359818	nicotine 4 MG Oral Lozenge	SCD	7c2e0872-75f6-4c4f-afff-3579375708de	6
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	7c2e0872-75f6-4c4f-afff-3579375708de	6
359818	nicotine 4 MG Troche	SY	7c2e0872-75f6-4c4f-afff-3579375708de	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-1338-09	00536133809	3 BOTTLE, PLASTIC in 1 BOX (0536-1338-09) / 24 LOZENGE in 1 BOTTLE, PLASTIC		2021-09-17	0000-00-00	No	No	Current
0536-1338-35	00536133835	24 LOZENGE in 1 BOTTLE, PLASTIC (0536-1338-35)	24 lozenge	2021-09-17		No	No	Current