Nicotine Polacrilex

Product NDC: 43598-488
Requested package NDC: 43598-488-24
11-digit product format: 435980488
Labeler code: 43598
Product ID: 43598-488_ea14d88d-2ad8-b2e9-bf8f-8a299e66d618
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc.
Application: ANDA213233
Marketing category: ANDA
Marketing start: 2020-10-01
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 1.

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
A213233-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2020-08-04
A213233-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2020-08-04

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 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`87673890dc5c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nicotine Polacrilex
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
359817	Internal RxNorm lookup
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
6b0342dd-120f-a16e-098a-dc45b14d3d3a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43598-488-10	Drug Facts
43598-488-10	Drug Facts
43598-488-12	Drug Facts
43598-488-12	Drug Facts
43598-488-13	Drug Facts
43598-488-13	Drug Facts
43598-488-14	Drug Facts
43598-488-14	Drug Facts
43598-488-16	Drug Facts
43598-488-16	Drug Facts
43598-488-17	Drug Facts
43598-488-17	Drug Facts
43598-488-18	Drug Facts
43598-488-18	Drug Facts
43598-488-19	Drug Facts
43598-488-19	Drug Facts
43598-488-22	Drug Facts
43598-488-22	Drug Facts
43598-488-23	Drug Facts
43598-488-23	Drug Facts
43598-488-24	Drug Facts
43598-488-24	Drug Facts
43598-488-27	Drug Facts
43598-488-27	Drug Facts
43598-488-29	Drug Facts
43598-488-29	Drug Facts
43598-488-48	Drug Facts
43598-488-48	Drug Facts
43598-488-54	Drug Facts
43598-488-54	Drug Facts
43598-488-72	Drug Facts
43598-488-72	Drug Facts
43598-488-73	Drug Facts
43598-488-73	Drug Facts
43598-488-74	Drug Facts
43598-488-74	Drug Facts
43598-488-81	Drug Facts
43598-488-81	Drug Facts
43598-488-96	Drug Facts
43598-488-96	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-488	NICOTINE POLACRILEX LOZENGE [DR. REDDY'S LABORATORIES INC.]	6	Current NDC, Legacy NDC	20240706_6b0342dd-120f-a16e-098a-dc45b14d3d3a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Habitrol Lozenge Cherry	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	5a464242-7d63-141e-808e-c41676cf4b78	2026-07-09	Warnings	Exact identifier application applno (ANDA): 213233 application number: ANDA213233
Nicotine Polacrilex	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	6b0342dd-120f-a16e-098a-dc45b14d3d3a	2026-07-09	Warnings	Exact identifier application applno (ANDA): 213233 application number: ANDA213233 ndc (package): 43598-488-24 ndc (product): 43598-488 ndc11 (package): 43598048824

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
2548896	Habitrol 2 MG Oral Lozenge	PSN	5a464242-7d63-141e-808e-c41676cf4b78	6
2548898	Habitrol 4 MG Oral Lozenge	PSN	5a464242-7d63-141e-808e-c41676cf4b78	6
359817	nicotine 2 MG Oral Lozenge	PSN	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
359817	nicotine 2 MG Oral Lozenge	PSN	5a464242-7d63-141e-808e-c41676cf4b78	6
359818	nicotine 4 MG Oral Lozenge	PSN	5a464242-7d63-141e-808e-c41676cf4b78	6
359818	nicotine 4 MG Oral Lozenge	PSN	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
2548896	nicotine 2 MG Oral Lozenge [Habitrol]	SBD	5a464242-7d63-141e-808e-c41676cf4b78	6
2548898	nicotine 4 MG Oral Lozenge [Habitrol]	SBD	5a464242-7d63-141e-808e-c41676cf4b78	6
359817	nicotine 2 MG Oral Lozenge	SCD	5a464242-7d63-141e-808e-c41676cf4b78	6
359817	nicotine 2 MG Oral Lozenge	SCD	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
359818	nicotine 4 MG Oral Lozenge	SCD	5a464242-7d63-141e-808e-c41676cf4b78	6
359818	nicotine 4 MG Oral Lozenge	SCD	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
2548896	Habitrol 2 MG Oral Lozenge	SY	5a464242-7d63-141e-808e-c41676cf4b78	6
2548898	Habitrol 4 MG Oral Lozenge	SY	5a464242-7d63-141e-808e-c41676cf4b78	6
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	5a464242-7d63-141e-808e-c41676cf4b78	6
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
359817	nicotine 2 MG Troche	SY	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
359817	nicotine 2 MG Troche	SY	5a464242-7d63-141e-808e-c41676cf4b78	6
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	5a464242-7d63-141e-808e-c41676cf4b78	6
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
359818	nicotine 4 MG Troche	SY	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
359818	nicotine 4 MG Troche	SY	5a464242-7d63-141e-808e-c41676cf4b78	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-488-24	43598048824	1 BOTTLE in 1 CARTON (43598-488-24) / 24 LOZENGE in 1 BOTTLE	1 bottle	2020-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Dr. Reddy's Laboratories Inc.	2026-07-09	HUMAN OTC DRUG LABEL	7
Drug Facts	Dr. Reddy's Laboratories Inc. \| Quality Packaging Specialists International, LLC	2026-07-09	HUMAN OTC DRUG LABEL	7