Sunmark Nicotine

Product NDC: 49348-572
Requested package NDC: 49348-572-08
11-digit product format: 493480572
Labeler code: 49348
Product ID: 49348-572_179d7248-c3fa-45c0-9b67-8e20ee1cc0ee
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA076789
Marketing category: ANDA
Marketing start: 2005-06-18
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 4 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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	49348-572	49348-572-08	D	Discontinued by firm		2026-08-03

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
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 · 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076789-001	NICOTINE POLACRILEX	EQ 4MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-572-08	EA - Each	49348-572	8bb1152c-928a-42f4-afa6-20929ca625a9	1	2012-07-24
49348-572-36	EA - Each	49348-572	751aabd5-7e97-4861-9cbe-8370acaa3584	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]	4
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]	4
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]	4
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]	4
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]	4
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]	4
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]	4
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-572	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [STRATEGIC SOURCING SERVICES LLC]	10	Legacy NDC	20241225_8f7e5952-4119-4a92-a016-81428d6c86c1.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
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
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
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	d146d768-b975-462c-bc94-c2132e1bdac7	2023-08-28	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-572-08	49348057208	50 BLISTER PACK in 1 CARTON (49348-572-08) > 1 GUM, CHEWING in 1 BLISTER PACK	50 blister pack	2005-06-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Nicotine Polacrilex Gum 4 mg (nicotine) Drug Facts	Strategic Sourcing Services LLC	2024-12-23	HUMAN OTC DRUG LABEL	10