Nicotine Polacrilex

Product NDC: 70000-0348
11-digit product format: 700000348
Labeler code: 70000
Product ID: 70000-0348_995f5f15-e607-4cca-85e3-ec8942812bce
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: BUCCAL
Labeler: CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Application: ANDA204794
Marketing category: ANDA
Marketing start: 2018-07-03
Substance: NICOTINE
Active strength: 2 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204794-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2016-05-10

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 · 41 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	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204794-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2016-05-10	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nicotine Polacrilex
Brand name suffix: Coated Ice Mint
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
311975	Internal RxNorm lookup
314119	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
b075c3cb-d610-4a9c-8cf0-e4b9001bc86a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
70000-0348-1	Nicotine PolacrilexCoated Ice Mint	20 in 1 CARTON	GUM, CHEWING	20	25
70000-0348-1	Nicotine PolacrilexCoated Ice Mint	1 in 1 BLISTER PACK	GUM, CHEWING	1	25
70000-0348-2	Nicotine PolacrilexCoated Ice Mint	100 in 1 CARTON	GUM, CHEWING	100	25
70000-0348-2	Nicotine PolacrilexCoated Ice Mint	1 in 1 BLISTER PACK	GUM, CHEWING	1	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0348-1	EA - Each	70000-0348	87d8a12d-3cbe-4deb-acb3-7323b2a029b6	1	2019-02-13
70000-0348-2	EA - Each	70000-0348	d6d02b52-9395-41d9-9909-59e1044838dc	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0348	NICOTINE POLACRILEX COATED ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING [CARDINAL HEALTH (LEADER) 70000]	23	Current NDC, Legacy NDC, 4 package rows	20241122_b075c3cb-d610-4a9c-8cf0-e4b9001bc86a.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Polacrilex Coated Ice Mint	NICOTINE POLACRILEX	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	b075c3cb-d610-4a9c-8cf0-e4b9001bc86a	2026-04-13	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794 ndc (product): 70000-0348
Nicotine Polacrilex	NICOTINE POLACRILEX	Chain Drug Consortium, LLC	9c115cd5-1952-4f1e-8e88-27f2c528e91f	2026-03-26	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794
Nicotine Polacrilex coated ice mint	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	c21147f5-da96-424c-9058-24eb751b64ea	2026-03-17	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794
Nicotine Polacrilex	NICOTINE POLACRILEX	Walgreens	b3e33137-bf40-4801-b01f-27a0d41edba4	2026-02-10	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794
Nicotine Polacrilex coated ice mint	NICOTINE POLACRILEX	CVS Pharmacy	e4e3fd5f-1ed1-4a18-9c31-7224cae77ded	2024-10-03	Warnings	Exact identifier application applno (ANDA): 204794 application number: ANDA204794

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
314119	nicotine polacrilex 2 MG Chewing Gum	PSN	b075c3cb-d610-4a9c-8cf0-e4b9001bc86a	25
311975	nicotine polacrilex 4 MG Chewing Gum	PSN	b075c3cb-d610-4a9c-8cf0-e4b9001bc86a	25
314119	nicotine 2 MG Chewing Gum	SCD	b075c3cb-d610-4a9c-8cf0-e4b9001bc86a	25
311975	nicotine 4 MG Chewing Gum	SCD	b075c3cb-d610-4a9c-8cf0-e4b9001bc86a	25
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	b075c3cb-d610-4a9c-8cf0-e4b9001bc86a	25
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	b075c3cb-d610-4a9c-8cf0-e4b9001bc86a	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0348-1	70000034801	20 BLISTER PACK in 1 CARTON (70000-0348-1) / 1 GUM, CHEWING in 1 BLISTER PACK	20 blister pack	2018-07-03	0000-00-00	No	No	Current
70000-0348-2	70000034802	100 BLISTER PACK in 1 CARTON (70000-0348-2) / 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2018-07-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotine Polacrilex Coated Ice Mint 2 mg and 4 mg - Leader	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	2026-04-13	HUMAN OTC DRUG LABEL	25