Nicotine Polacrilex

Product NDC: 70000-0345
11-digit product format: 700000345
Labeler code: 70000
Product ID: 70000-0345_905563ef-1910-4436-a4cd-351213b503af
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: BUCCAL
Labeler: CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Application: ANDA074507
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
A074507-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			1999-03-15

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	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074507-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	1999-03-15	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nicotine Polacrilex
Brand name suffix: Original
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
4acbda22-9c87-49f2-ad5f-55b1e54bdf2e	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
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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	Strength	SPL version
70000-0345-1	Nicotine PolacrilexOriginal	1 in 1 BLISTER PACK	GUM, CHEWING	1		12
70000-0345-1	Nicotine PolacrilexOriginal	50 in 1 CARTON	GUM, CHEWING	50		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0345-1	EA - Each	70000-0345	38fd4c86-c3b5-4870-8099-328f4a912849	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0345	NICOTINE POLACRILEX ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CARDINAL HEALTH (LEADER) 70000]	10	Current NDC, Legacy NDC, 2 package rows	20241121_4acbda22-9c87-49f2-ad5f-55b1e54bdf2e.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	P & L Development, LLC	c65c1c40-4c8f-40bb-ace4-8bbc9ecf630e	2026-06-16	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine Polacrilex original	NICOTINE POLACRILEX	Walgreens	f759d9b2-35e0-4b88-9219-4c0e483af5c4	2026-05-19	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine Polacrilex original	NICOTINE POLACRILEX	CVS Pharmacy	62231539-ae9f-4665-ba59-bef047e93d8a	2026-05-08	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine Polacrilex Original	NICOTINE POLACRILEX	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	4acbda22-9c87-49f2-ad5f-55b1e54bdf2e	2026-04-10	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507 ndc (product): 70000-0345
Nicotine	NICOTINE POLACRILEX	Walgreens	69ffbb37-e26c-4214-8d09-0bbabed25310	2026-03-20	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	be693c28-58d5-42ed-ab86-2a28af931051	2026-03-17	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Rugby Nicotine Polacrilex Gum, Original Flavor	NICOTINE POLACRILEX	Rugby Laboratories	1fc88637-4329-486e-82ab-19eeb06080a6	2026-02-24	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine	NICOTINE POLACRILEX	McKesson Corporation dba SKY Packaging	9ac37719-24c2-4ec7-9fb3-6408d8a5fc7a	2026-01-09	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine Polacrilex, Original	NICOTINE POLACRILEX	Chain Drug Consortium, LLC	cb67cd5e-9264-4530-a678-da299476f356	2025-06-30	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine	NICOTINE POLACRILEX	The Kroger Co.	8c81c885-1d56-4dca-b9bc-adfc9bf58051	2025-02-25	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507
Nicotine Polacrilex Original Flavor	NICOTINE POLACRILEX	Publix Supermarkets, Inc.	540c88bd-70dc-416a-8d8e-0a33b2b29563	2024-07-30	Warnings	Exact identifier application applno (ANDA): 074507 application number: ANDA074507

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	4acbda22-9c87-49f2-ad5f-55b1e54bdf2e	12
311975	nicotine polacrilex 4 MG Chewing Gum	PSN	4acbda22-9c87-49f2-ad5f-55b1e54bdf2e	12
314119	nicotine 2 MG Chewing Gum	SCD	4acbda22-9c87-49f2-ad5f-55b1e54bdf2e	12
311975	nicotine 4 MG Chewing Gum	SCD	4acbda22-9c87-49f2-ad5f-55b1e54bdf2e	12
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	4acbda22-9c87-49f2-ad5f-55b1e54bdf2e	12
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	4acbda22-9c87-49f2-ad5f-55b1e54bdf2e	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0345-1	70000034501	50 BLISTER PACK in 1 CARTON (70000-0345-1) / 1 GUM, CHEWING in 1 BLISTER PACK	50 blister pack	2018-07-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotine Polacrilex Original 2 mg and 4 mg - Leader	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	2026-04-10	HUMAN OTC DRUG LABEL	12