Nicotine Polacrilex

Product NDC: 68016-560
11-digit product format: 680160560
Labeler code: 68016
Product ID: 68016-560_4004f343-1acc-48c7-a332-f0fbf9aca9b2
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: BUCCAL
Labeler: Chain Drug Consortium, LLC
Application: ANDA078697
Marketing category: ANDA
Marketing start: 2014-10-01
Marketing end: 2026-12-31
Substance: NICOTINE
Active strength: 4 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
A078697-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2008-12-29

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	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078697-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2008-12-29	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nicotine Polacrilex
Brand name suffix: Coated Mint

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	4 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
b4ac0a22-3556-4591-aa7b-e09c6010adc8	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	Strength	SPL version
68016-560-00	Nicotine PolacrilexCoated Mint	2 in 1 CARTON	GUM, CHEWING	2		33
68016-560-00	Nicotine PolacrilexCoated Mint	10 in 1 BLISTER PACK	GUM, CHEWING	10		33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-560-00	EA - Each	68016-560	cbe0a3de-4544-43f9-91bf-0cccaadb363b	1	2017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4
ACACIA	INACTIVE INGREDIENT	5C5403N26O	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	NICOTINE POLACRILEX, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-560	NICOTINE POLACRILEX COATED MINT (NICOTINE POLACRILEX) GUM, CHEWING [CHAIN DRUG CONSORTIUM, LLC]	25	Current NDC, Legacy NDC, 2 package rows	20221021_b4ac0a22-3556-4591-aa7b-e09c6010adc8.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE POLACRILEX	Rugby Laboratories	621eb214-0716-4306-829f-6185a77f24d5	2026-07-16	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex coated mint	NICOTINE POLACRILEX	CVS Pharmacy	84daeb67-5982-4b9e-b56a-4cc6a223a3f8	2026-05-05	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex Coated Mint	NICOTINE POLACRILEX	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	2c420ee4-0ed0-4a3f-bc92-202d825d0ca3	2026-04-13	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex Coated Mint	NICOTINE POLACRILEX	Chain Drug Consortium, LLC	b4ac0a22-3556-4591-aa7b-e09c6010adc8	2026-03-26	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697 ndc (product): 68016-560
Nicotine Polacrilex	NICOTINE POLACRILEX	Walgreens	826f63b2-fd18-4213-be38-a430d78897cb	2026-03-25	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	AmerisourceBergen (Good Neighbor Pharmacy) 46122	53c82cf8-d97b-4a5a-a357-fb74a74d1ef3	2026-03-18	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex Coated Mint	NICOTINE POLACRILEX	Publix Supermarkets, Inc.	a6ef9fd0-9706-4924-b7f5-e2562b9d99e0	2026-02-23	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	ed5722d7-746b-468e-89b5-506055d12bbd	2025-12-23	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Rising Pharma Holdings, Inc.	e86b9c22-7ee0-4bd0-adfd-a7b087b1dd71	2025-12-06	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	AAFES/Your Military Exchanges	27308f6b-43b9-4b1d-af6b-7a39b79def03	2025-05-08	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Lucy Goods, Inc.	b97d27d2-a6e1-40da-bdc2-eaf7b88321f6	2025-04-29	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4af800f9-bcb3-4320-8d32-f1bfd54ee5e9	2025-04-03	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Quitine LLC	dc142c50-5310-43f5-a9e5-e174116685f8	2024-12-17	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697
Nicotine Polacrilex	NICOTINE POLACRILEX	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5b30fa5a-fff7-46ec-9f33-fda633cc315d	2024-11-06	Warnings	Exact identifier application applno (ANDA): 078697 application number: ANDA078697

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	b4ac0a22-3556-4591-aa7b-e09c6010adc8	33
311975	nicotine polacrilex 4 MG Chewing Gum	PSN	b4ac0a22-3556-4591-aa7b-e09c6010adc8	33
314119	nicotine 2 MG Chewing Gum	SCD	b4ac0a22-3556-4591-aa7b-e09c6010adc8	33
311975	nicotine 4 MG Chewing Gum	SCD	b4ac0a22-3556-4591-aa7b-e09c6010adc8	33
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	b4ac0a22-3556-4591-aa7b-e09c6010adc8	33
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	b4ac0a22-3556-4591-aa7b-e09c6010adc8	33

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-560-00	68016056000	2 BLISTER PACK in 1 CARTON (68016-560-00) / 10 GUM, CHEWING in 1 BLISTER PACK	2 blister pack	2014-10-01	2026-12-31	No	No	Current