Nicotine Polacrilex Lozenge Mint

Product NDC: 63868-732
Requested package NDC: 63868-732-24
11-digit product format: 638680732
Labeler code: 63868
Product ID: 63868-732_618550c1-391c-c6a7-c2b5-19d3bfc78419
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex Lozenge 4 mg
Dosage form: LOZENGE
Route: ORAL
Labeler: Chain Drug Marketing Association INC
Application: ANDA212796
Marketing category: ANDA
Marketing start: 2021-04-01
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

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	63868-732	63868-732-24	I	Inactivated by FDA		2026-08-17

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
A212796-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2020-01-08
A212796-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2020-01-08

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 · 76 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	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212796-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212796-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-01-08	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-732-24	2024-01-30	C162847	48780-1	1030e365-6cb1-111a-e063-dadaa90a10e2	Drug Facts
63868-732-72	2024-01-30	C162847	48780-1	1030e365-6cb1-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-732-24	EA - Each	63868-732	f8bde199-5f35-48c8-a39a-82d71a16fafc	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-732	NICOTINE POLACRILEX LOZENGE MINT (NICOTINE POLACRILEX LOZENGE 2 MG) LOZENGE NICOTINE POLACRILEX LOZENGE MINT (NICOTINE POLACRILEX LOZENGE 4 MG) LOZENGE [CHAIN DRUG MARKETING ASSOCIATION INC]	4	Current NDC, Legacy NDC	20240730_e0234492-d92d-ee93-493f-1099d4544722.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Habitrol Nicotine Polacrilex Lozenge Mint	NICOTINE POLACRILEX LOZENGE 2 MG	Dr. Reddy's Laboratories Inc.	836bae74-076b-3c92-dee9-22b8519b529d	2026-07-09	Warnings	Exact identifier application applno (ANDA): 212796 application number: ANDA212796
Nicotine Polacrilex	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	b0fdb36d-4cf5-8a91-3da1-90e3587450f9	2026-07-09	Warnings	Exact identifier application applno (ANDA): 212796 application number: ANDA212796
Nicotine Polacrilex	NICOTINE POLACRILEX	Bryant Ranch Prepack	b2f4506b-b575-4ed8-b10b-935451ea3451	2025-08-26	Warnings	Exact identifier application applno (ANDA): 212796 application number: ANDA212796
Nicotine Polacrilex	NICOTINE POLACRILEX	Bryant Ranch Prepack	a3ca2479-9703-41de-918a-881da16e5c98	2025-08-26	Warnings	Exact identifier application applno (ANDA): 212796 application number: ANDA212796

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	e0234492-d92d-ee93-493f-1099d4544722	4
359818	nicotine 4 MG Oral Lozenge	PSN	e0234492-d92d-ee93-493f-1099d4544722	4
359817	nicotine 2 MG Oral Lozenge	SCD	e0234492-d92d-ee93-493f-1099d4544722	4
359818	nicotine 4 MG Oral Lozenge	SCD	e0234492-d92d-ee93-493f-1099d4544722	4
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	e0234492-d92d-ee93-493f-1099d4544722	4
359817	nicotine 2 MG Troche	SY	e0234492-d92d-ee93-493f-1099d4544722	4
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	e0234492-d92d-ee93-493f-1099d4544722	4
359818	nicotine 4 MG Troche	SY	e0234492-d92d-ee93-493f-1099d4544722	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-732-24	63868073224	1 BOTTLE in 1 CARTON (63868-732-24) / 24 LOZENGE in 1 BOTTLE	1 bottle	2021-04-01	0000-00-00	No	No	Current