Nicotine Polacrilex, Original

Product NDC: 68016-286
11-digit product format: 680160286
Labeler code: 68016
Product ID: 68016-286_b3555bc9-16a9-4ba6-a2cb-5c40ac2129c4
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: BUCCAL
Labeler: Chain Drug Consortium, LLC
Application: ANDA074507
Marketing category: ANDA
Marketing start: 2013-07-01
Marketing end: 2026-12-31
Substance: NICOTINE
Active strength: 2 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
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, Original

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
cb67cd5e-9264-4530-a678-da299476f356	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
68016-286-62	Nicotine Polacrilex, Original	11 in 1 CARTON	GUM, CHEWING	11		15
68016-286-62	Nicotine Polacrilex, Original	10 in 1 BLISTER PACK	GUM, CHEWING	10		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-286-62	EA - Each	68016-286	75d4624f-31b1-4615-8d9a-69fd42d16675	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2
FD&C RED NO. 4	INACTIVE INGREDIENT	X3W0AM1JLX	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-286	NICOTINE POLACRILEX, ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	11	Current NDC, Legacy NDC, 2 package rows	20221122_cb67cd5e-9264-4530-a678-da299476f356.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
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 ndc (product): 68016-286
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	cb67cd5e-9264-4530-a678-da299476f356	15
311975	nicotine polacrilex 4 MG Chewing Gum	PSN	cb67cd5e-9264-4530-a678-da299476f356	15
314119	nicotine 2 MG Chewing Gum	SCD	cb67cd5e-9264-4530-a678-da299476f356	15
311975	nicotine 4 MG Chewing Gum	SCD	cb67cd5e-9264-4530-a678-da299476f356	15
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	cb67cd5e-9264-4530-a678-da299476f356	15
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	cb67cd5e-9264-4530-a678-da299476f356	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-286-62	68016028662	11 BLISTER PACK in 1 CARTON (68016-286-62) / 10 GUM, CHEWING in 1 BLISTER PACK	11 blister pack	2013-07-01	2026-12-31	No	No	Current