signature care nicotine

Product NDC: 21130-211
11-digit product format: 211300211
Labeler code: 21130
Product ID: 21130-211_bdf1a198-bce7-4934-86e1-2e45ddd743c7
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Safeway
Application: ANDA077007
Marketing category: ANDA
Marketing start: 2015-09-28
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 4 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21130-211		D	Discontinued by firm		2026-10-05
excluded package	package	21130-211	21130-211-05	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077007-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2006-01-31
A077007-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2006-01-31

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077007-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077007-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2006-01-31	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	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	Strength	SPL version
21130-211-05	signature care nicotine	3 in 1 CARTON	LOZENGE	3		3
21130-211-05	signature care nicotine	24 in 1 CONTAINER	LOZENGE	24		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]	1
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]	1
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]	1
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]	1
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]	1
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-211	SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]	3	Legacy NDC, 2 package rows	20180919_420c0858-c0af-45d0-b048-5d6275530317.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 4 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
up and up nicotine	NICOTINE POLACRILEX	Target Corporation	c0c667b8-7384-4970-8f27-f108192c3256	2024-02-20	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Good Sense Nicotine	NICOTINE POLACRILEX	A-S Medication Solutions	d84f27e4-c63b-4d04-9e65-bdb1a3594f92	2024-01-22	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine Polacrilex	NICOTINE POLACRILEX	A-S Medication Solutions	bee5365b-e7f1-493a-baec-8604bd5550e3	2023-12-09	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine Polacrilex	NICOTINE POLACRILEX	A-S Medication Solutions	6c814edf-0917-4e48-8d26-931b1db27880	2023-12-09	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	7eed43bd-b26c-41cd-b2bc-74d6c15b376c	2023-10-25	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
care one nicotine	NICOTINE POLACRILEX	American Sales Company	1b6be939-cd9d-4ab4-b291-096cf498cf92	2023-10-20	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
careone nicotine	NICOTINE POLACRILEX	American Sales Company	84ed0acf-dcd3-4d4a-8e5c-f75f48993b34	2023-10-20	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
foster and thrive nicotine	NICOTINE POLACRILEX	Strategic Sourcing Services LLC	60420337-ce44-403e-943f-2a7964e73306	2023-10-16	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
euqate nicotine	NICOTINE POLACRILEX	WALMART INC.	c1764aad-1da4-4e4e-b6b0-5a3df1edda85	2023-08-31	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Nicotine	NICOTINE POLACRILEX	CVS Pharmacy	e23ad78b-f151-44bb-8dfd-7e933c0d1152	2023-08-30	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
Topcare Nicotine	NICOTINE POLACRILEX	Topco Associates LLC	a0ceda92-78e7-417f-adfc-a085f9b18584	2023-08-28	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	d6566f92-cf41-4032-a66b-3d1cdf661f33	2023-08-01	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
equate nicotine	NICOTINE POLACRILEX	WALMART INC.	0f625e1a-be08-4460-a588-8b42282ac121	2023-06-15	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
topcare nicotine	NICOTINE POLACRILEX	Topco Associates LLC	872d8ba6-881c-49f2-9848-1ed3eed76860	2023-06-15	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
kirkland signature quit 2	NICOTINE POLACRILEX	Costco Wholesale Company	cb462e10-124e-4ea3-9261-8c1fc7a9e1a6	2023-05-18	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
kirkland signature quit 4	NICOTINE POLACRILEX	Costco Wholesale Company	cd1c3493-242c-4981-8561-ebbea938628f	2023-05-12	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
signature care nicotine	NICOTINE POLACRILEX	Safeway	cb2624de-3908-4091-aea1-f0dc76abd633	2022-11-15	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	afc71ce1-ded2-4259-a9e1-faca692b90a1	2022-01-11	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
basic care nicotine	NICOTINE POLACRILEX	Amazon.com Services LLC	8cc8de15-5906-4749-99f2-2884c6a1842a	2021-09-07	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007
exchange select nicotine	NICOTINE POLACRILEX	Army & Air Force Exchange Service	0294974c-8d07-4a2e-b929-648c712b6ebe	2021-06-01	Warnings	Exact identifier application applno (ANDA): 077007 application number: ANDA077007

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
359818	nicotine 4 MG Oral Lozenge	PSN	420c0858-c0af-45d0-b048-5d6275530317	3
359818	nicotine 4 MG Oral Lozenge	SCD	420c0858-c0af-45d0-b048-5d6275530317	3
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	420c0858-c0af-45d0-b048-5d6275530317	3
359818	nicotine 4 MG Troche	SY	420c0858-c0af-45d0-b048-5d6275530317	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-211-05	21130021105	3 CONTAINER in 1 CARTON (21130-211-05) > 24 LOZENGE in 1 CONTAINER	3 container	2015-09-28	0000-00-00	No	No	Current