foster and thrive nicotine

Product NDC: 70677-1164
11-digit product format: 706771164
Labeler code: 70677
Product ID: 70677-1164_7079d131-81b0-43f5-81f2-c25c2efa3ae8
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: GUM, CHEWING
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA078547
Marketing category: ANDA
Marketing start: 2024-06-19
Substance: NICOTINE
Active strength: 2 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078547-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL			2007-05-24

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078547-001	NICOTINE POLACRILEX	EQ 2MG BASE	GUM, CHEWING / BUCCAL	2007-05-24	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: foster and thrive nicotine
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
c5290759-84c0-4999-8222-d03a0b61bcd5	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
70677-1164-1	foster and thrive nicotine	1 in 1 BLISTER PACK	GUM, CHEWING	1		3
70677-1164-1	foster and thrive nicotine	100 in 1 CARTON	GUM, CHEWING	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70677-1164-1	EA - Each	70677-1164	b8f1a8c6-8139-455b-987f-1d52b7b38dae	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70677-1164	FOSTER AND THRIVE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [STRATEGIC SOURCING SERVICES LLC]	2	Current NDC, 2 package rows	20240621_c5290759-84c0-4999-8222-d03a0b61bcd5.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
care one nicotine	NICOTINE POLACRILEX	American Sales Company	e9558a4e-a0ad-4391-9b9c-85edb61523c1	2026-06-17	Warnings	Exact identifier application applno (ANDA): 078547 application number: ANDA078547
Basic Care Nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	a7e3da43-693b-44df-8566-4847edae9d61	2026-06-10	Warnings	Exact identifier application applno (ANDA): 078547 application number: ANDA078547
quitine nicotine	NICOTINE POLACRILEX	QUITINE LLC	486400cd-f2ef-4e14-8cf7-37954e1ed4d4	2026-05-20	Warnings	Exact identifier application applno (ANDA): 078547 application number: ANDA078547
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	c5290759-84c0-4999-8222-d03a0b61bcd5	2026-04-27	Warnings	Exact identifier application applno (ANDA): 078547 application number: ANDA078547 ndc (product): 70677-1164
good sense nicotine	NICOTINE POLACRILEX	L. Perrigo Company	8647dca6-676b-4279-8e20-17153feb9974	2026-01-19	Warnings	Exact identifier application applno (ANDA): 078547 application number: ANDA078547

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	c5290759-84c0-4999-8222-d03a0b61bcd5	3
314119	nicotine 2 MG Chewing Gum	SCD	c5290759-84c0-4999-8222-d03a0b61bcd5	3
314119	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum	SY	c5290759-84c0-4999-8222-d03a0b61bcd5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70677-1164-1	70677116401	100 BLISTER PACK in 1 CARTON (70677-1164-1) / 1 GUM, CHEWING in 1 BLISTER PACK	100 blister pack	2024-06-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Nicotine Gum Drug Facts	Strategic Sourcing Services LLC	2026-04-27	HUMAN OTC DRUG LABEL	3