Health Mart nicotine polacrilex

Product NDC: 62011-0199
11-digit product format: 620110199
Labeler code: 62011
Product ID: 62011-0199_2a4b76e5-3429-4431-9541-6971a04d2279
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA203690
Marketing category: ANDA
Marketing start: 2013-06-10
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 2 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	62011-0199		D	Discontinued by firm		2026-10-05
excluded package	package	62011-0199	62011-0199-1	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62011-0199-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62011-0199-1	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A203690-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2012-10-09
A203690-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2012-10-09

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	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203690-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203690-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2012-10-09	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62011-0199-1	EA - Each	62011-0199	d8d6af61-495c-40b9-9044-a96879bbb46e	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	HEALTH MART NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [MCKESSON]	2
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	HEALTH MART NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [MCKESSON]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	HEALTH MART NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [MCKESSON]	2
CALCIUM POLYCARBOPHIL	INACTIVE INGREDIENT	8F049NKY49	HEALTH MART NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [MCKESSON]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HEALTH MART NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [MCKESSON]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	HEALTH MART NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [MCKESSON]	2
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	HEALTH MART NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [MCKESSON]	2
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	HEALTH MART NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [MCKESSON]	2
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	HEALTH MART NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [MCKESSON]	2
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	HEALTH MART NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [MCKESSON]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62011-0199	HEALTH MART NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [STRATEGIC SOURCING SERVICES LLC]	7	Legacy NDC	20250104_c96da894-cc80-46af-8ec4-ff52603ae424.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 5 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
signature care nicotine	NICOTINE POLACRILEX	Safeway	22010ed8-7fa6-402a-a314-523538183a55	2018-11-01	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
signature care nicotine	NICOTINE POLACRILEX	Safeway	664c3faf-7cab-4bda-8987-07acb8e1142b	2018-10-31	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
exchange select nicotine	NICOTINE POLACRILEX	Army & Air Force Exchange Service	e926cf6f-305a-4912-be07-a45bb7905822	2018-09-21	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690
berkley and jensen nicotine	NICOTINE POLACRILEX	BJWC	357123fc-0972-4683-ab52-f95d46c1b6c9	2017-11-09	Warnings	Exact identifier application applno (ANDA): 203690 application number: ANDA203690

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6M3C89ZY6R	NICOTINE	54-11-5	NICOTINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62011-0199-1	62011019901	3 CONTAINER in 1 CARTON (62011-0199-1) > 27 LOZENGE in 1 CONTAINER	3 container	2013-06-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Nicotine Polacrilex Lozenge Drug Facts	Strategic Sourcing Services LLC	2025-01-02	HUMAN OTC DRUG LABEL	7