Home NDC 11822-0344 Nicotine
Product NDC 11822-0344
11-digit product format 118220344
Labeler code 11822
Product ID 11822-0344_21806b88-889d-4f5c-b414-fb6b95d902bb
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form LOZENGE
Route ORAL
Labeler Rite Aid Corporation
Application ANDA077007
Marketing category ANDA
Marketing start 2006-02-24
Marketing end 2026-12-31
Substance NICOTINE
Active strength 2 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 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 · 82 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 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…2022-03-09 01:35 UTC 2022-03 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 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 Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11822-0344 NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION] 6 Current NDC, Legacy NDC, 6 package rows 20230720_9e411b49-c8c4-43f8-a402-5ca2d96db131.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 4 · 75 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11822-0344-0 11822034400 4 CONTAINER in 1 CARTON (11822-0344-0) / 27 LOZENGE in 1 CONTAINER 4 container 2009-09-03 0000-00-00 No No Current 11822-0344-1 11822034401 3 CONTAINER in 1 CARTON (11822-0344-1) / 24 LOZENGE in 1 CONTAINER 3 container 2011-09-02 0000-00-00 No No Current 11822-0344-5 11822034405 7 CONTAINER in 1 CARTON (11822-0344-5) / 24 LOZENGE in 1 CONTAINER 7 container 2023-07-19 2026-10-01 No No Historical