NDC 45802-089-01 - Nicotine Polacrilex

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 45802-089
Requested NDC: 45802-089-01
Package NDCs from labels: 45802-089-01, 45802-089-02
Manufacturer: Padagis Israel Pharmaceuticals Ltd
Effective date: 2026-04-30
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Nicotine Polacrilex - Padagis Israel Pharmaceuticals Ltd	Padagis Israel Pharmaceuticals Ltd	2026-04-30	HUMAN OTC DRUG LABEL
Nicotine Polacrilex - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-07-29	HUMAN OTC DRUG LABEL
Nicotine Polacrilex - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-04-03	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-089-01	Nicotine Polacrilex	27 in 1 CONTAINER	LOZENGE	27		4
45802-089-02	Nicotine Polacrilex	3 in 1 CARTON	LOZENGE	3		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-089	NICOTINE POLACRILEX LOZENGE [PADAGIS ISRAEL PHARMACEUTICALS LTD]	3	Current NDC, Legacy NDC, 2 package rows	20250228_b765570e-e5b5-48e4-b4d2-2a85ac19a2ea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-089-01	EA - Each	45802-089	2761a663-9f19-4540-8d44-12ddfad2eee4	1	2026-05-22

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 40 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
signature care nicotine	NICOTINE POLACRILEX	Safeway	664c3faf-7cab-4bda-8987-07acb8e1142b	2018-10-31	Warnings	Exact identifier application number: ANDA203690 unii: 6M3C89ZY6R
exchange select nicotine	NICOTINE POLACRILEX	Army & Air Force Exchange Service	e926cf6f-305a-4912-be07-a45bb7905822	2018-09-21	Warnings	Exact identifier application number: ANDA203690 unii: 6M3C89ZY6R
berkley and jensen nicotine	NICOTINE POLACRILEX	BJWC	357123fc-0972-4683-ab52-f95d46c1b6c9	2017-11-09	Warnings	Exact identifier application number: ANDA203690 unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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