Equate nicotine

Product NDC: 49035-170
11-digit product format: 490350170
Labeler code: 49035
Product ID: 49035-170_09305580-0cf9-4250-80fd-c5d62b73b1db
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Wal-Mart Stores Inc
Application: ANDA076789
Marketing category: ANDA
Marketing start: 2005-03-22
Substance: NICOTINE
Active strength: 4 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49035-170	49035-170-96	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076789-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL			2004-09-16

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Equate nicotine
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311975	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
0eb7bd68-7260-404c-a928-7898c6c26572	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
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
49035-170-29	Equate nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1	9
49035-170-29	Equate nicotine	220 in 1 CARTON	GUM, CHEWING	220	9
49035-170-96	Equate nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1	9
49035-170-96	Equate nicotine	170 in 1 CARTON	GUM, CHEWING	170	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-170-29	EA - Each	49035-170	6b2613ef-0a98-4eb1-b105-afc29e974a53	1	2023-03-13
49035-170-96	EA - Each	49035-170	97838c9c-b752-4373-853d-2b4e14a66d01	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]	3
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]	3
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]	3
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]	3
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]	3
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-170	EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]	8	Current NDC, Legacy NDC, 4 package rows	20250522_0eb7bd68-7260-404c-a928-7898c6c26572.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nicotine	NICOTINE POLACRILEX	Publix Super Markets Inc	ecdfe02c-813b-4c1e-9e02-d7c544a89644	2026-07-23	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
kirkland signature quit 4	NICOTINE POLACRILEX	Costco Wholesale Company	b9dd4e89-0023-4552-bdd6-1c046ce3bd87	2026-07-14	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	ae802de5-8e1b-439f-ab81-db4bd7241c91	2026-07-10	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
signature care nicotine	NICOTINE POLACRILEX	Safeway	3591828f-dff0-4cb7-ab0e-d43704243dc2	2026-06-12	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
nicotine	NICOTINE POLACRILEX	H E B	bbc4fd9f-b1f5-4691-b980-3424c91e4c88	2026-06-12	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
members mark nicotine	NICOTINE POLACRILEX	Sam's West Inc	8edad777-6491-4ab2-9835-709bf54d5f0c	2026-06-11	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	dc6b806a-f571-4d33-9b93-3dcd21ad0260	2026-06-09	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	63ac801f-02ed-43a1-a2a8-2ad35d8fd7a9	2026-06-09	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	d146d768-b975-462c-bc94-c2132e1bdac7	2026-05-02	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	1c49ddd3-0f2c-4310-acf1-edd42e3aafc5	2026-04-28	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
up and up uncoated original nicotine	NICOTINE POLACRILEX	Target Corporation	f837023e-29e1-49c5-89af-b491e8302fd9	2026-04-18	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
careone nicotine	NICOTINE POLACRILEX	American Sales Company	97926c62-b56a-4ce0-addb-037d90d297e7	2026-04-03	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
Equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	0eb7bd68-7260-404c-a928-7898c6c26572	2026-02-23	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789 ndc (product): 49035-170
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	1a916693-6092-4875-872a-7438816c0ddf	2026-02-12	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789
berkley and jensen nicotine	NICOTINE POLACRILEX	BJWC	cf91dba6-f461-4370-920b-bc148089afe7	2021-04-02	Warnings	Exact identifier application applno (ANDA): 076789 application number: ANDA076789

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
311975	nicotine polacrilex 4 MG Chewing Gum	PSN	0eb7bd68-7260-404c-a928-7898c6c26572	9
311975	nicotine 4 MG Chewing Gum	SCD	0eb7bd68-7260-404c-a928-7898c6c26572	9
311975	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum	SY	0eb7bd68-7260-404c-a928-7898c6c26572	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-170-29	49035017029	220 BLISTER PACK in 1 CARTON (49035-170-29) / 1 GUM, CHEWING in 1 BLISTER PACK	220 blister pack	2020-02-25	0000-00-00	No	No	Current
49035-170-96	49035017096	170 BLISTER PACK in 1 CARTON (49035-170-96) > 1 GUM, CHEWING in 1 BLISTER PACK	170 blister pack	2005-03-22	0000-00-00	No	No	Current