Home NDC 0363-9590 Nicotine
Product NDC 0363-9590
11-digit product format 003639590
Labeler code 0363
Product ID 0363-9590_22be9a90-9024-43fc-a56d-eacb6f29a310
Type HUMAN OTC DRUG
Nonproprietary name nicotine polacrilex
Dosage form LOZENGE
Route ORAL
Labeler Walgreens
Application ANDA210712
Marketing category ANDA
Marketing start 2021-05-28
Marketing end 2027-05-28
Substance NICOTINE
Active strength 2 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A210712-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 A210712-002 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06
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 · 80 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210712-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210712-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2019-09-06 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Nicotine 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 359817 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-9590 NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREENS] 6 Current NDC, Legacy NDC, 8 package rows 20230805_0135caa0-f5e9-471e-ac5f-6b9be8ddfcb0.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0363-9590-08 00363959008 4 BOTTLE, PLASTIC in 1 BOX (0363-9590-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC 2021-05-28 2027-05-28 No No Current 0363-9590-24 00363959024 1 BOTTLE, PLASTIC in 1 BOX (0363-9590-24) / 24 LOZENGE in 1 BOTTLE, PLASTIC 2021-05-28 2027-05-28 No No Current 0363-9590-27 00363959027 1 BOTTLE, PLASTIC in 1 BOX (0363-9590-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC 2021-05-28 2027-05-28 No No Current 0363-9590-72 00363959072 3 BOTTLE, PLASTIC in 1 BOX (0363-9590-72) / 24 LOZENGE in 1 BOTTLE, PLASTIC 2021-05-28 2027-05-28 No No Current