sunmark nicotine

Product NDC: 49348-573
11-digit product format: 493480573
Labeler code: 49348
Product ID: 49348-573_8056965e-f1cc-486e-bf5d-c6e867b5ba33
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA076775
Marketing category: ANDA
Marketing start: 2005-06-18
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 2 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49348-573		D	Discontinued by firm	2026-08-03
excluded package	package	49348-573	49348-573-08	D	Discontinued by firm	2026-08-03
excluded package	package	49348-573	49348-573-36	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
A076775-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG 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	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076775-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2004-09-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076775-001	NICOTINE POLACRILEX	EQ 2MG 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
49348-573-08	EA - Each	49348-573	2e38c60d-6ea2-49df-979b-d94d7871f372	1	2012-07-24
49348-573-36	EA - Each	49348-573	647c9360-fa95-411a-9897-544d1ceeb447	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
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
49348-573	SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [STRATEGIC SOURCING SERVICES LLC]	10	Legacy NDC	20241225_af1fe111-3c61-4664-8e30-31d1cf4f74dd.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
kirkland signature quit 2	NICOTINE POLACRILEX	Costco Wholesale Company	ccee1b99-e58b-4377-9ae8-9f215e2c975d	2026-07-14	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
TopCare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	beb2eddc-0fec-4f64-bceb-4e9bcee3616c	2026-06-19	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
berkley and jensen nicotine	NICOTINE POLACRILEX	BJWC	8fdfe95a-8bd9-4a77-a95d-0d373e279a4a	2026-06-19	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
NICOTINE	NICOTINE POLACRILEX	Publix Super Markets Inc	05f4c92b-1d57-4ef2-a53d-d4069d2730f3	2026-06-15	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
nicotine	NICOTINE POLACRILEX	Safeway	ed4fe766-1329-4d57-894d-3b977dd07b5c	2026-06-12	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
CareOne nicotine	NICOTINE POLACRILEX	American Sales Company	ffaa553c-7323-4d9c-87f4-2846bc51fa7c	2026-06-12	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
nicotine	NICOTINE POLACRILEX	H E B	8c288d15-d1ea-42b6-8cfb-f056d59fd3e0	2026-06-12	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
members mark nicotine	NICOTINE POLACRILEX	Sam's West Inc	2c43a498-a4fb-4ed1-b4ae-aecfd334945b	2026-06-11	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	90f2da70-c58f-44fb-bdbd-5c95440c1198	2026-06-08	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
Nicotine	NICOTINE POLACRILEX	Rite Aid Corporation	e808dd98-3307-4dcf-b042-910ea6c3170a	2026-04-28	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
up and up uncoated nicotine	NICOTINE POLACRILEX	Target Corporation	b7f79a60-4022-4bbe-ac13-67ec4de9f753	2026-04-17	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
Foster and Thrive Nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	b3dc0d9a-f85d-4d8a-b212-bddb692f85b8	2026-04-17	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
Good Sense Nicotine	NICOTINE POLACRILEX	L. Perrigo Company	7744ea8b-164a-4992-9874-a2b59bee585d	2026-02-18	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
Equate nicotine	NICOTINE POLACRILEX	Wal-Mart Stores Inc	da1ba4bc-6171-4cb8-a3e7-4972653ee269	2026-02-04	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775
nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	db0d922a-407f-49ac-b5d3-acc7112a373e	2026-01-15	Warnings	Exact identifier application applno (ANDA): 076775 application number: ANDA076775

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
49348-573-08	49348057308	50 BLISTER PACK in 1 CARTON (49348-573-08) > 1 GUM, CHEWING in 1 BLISTER PACK	50 blister pack	2005-06-18	0000-00-00	No	No	Current
49348-573-36	49348057336	110 BLISTER PACK in 1 CARTON (49348-573-36) > 1 GUM, CHEWING in 1 BLISTER PACK	110 blister pack	2005-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Nicotine Polacrilex Gum 2 mg (nicotine) Drug Facts	Strategic Sourcing Services LLC	2024-12-23	HUMAN OTC DRUG LABEL	10