Home NDC 41250-190 nicotine
Product NDC 41250-190
11-digit product format 412500190
Labeler code 41250
Product ID 41250-190_9e89ae28-ac76-4d10-8ccd-455f14f9f64b
Type HUMAN OTC DRUG
Nonproprietary name Nicotine polacrilex
Dosage form LOZENGE
Route ORAL
Labeler Meijer Distribution Inc
Application ANDA090711
Marketing category ANDA
Marketing start 2009-09-16
Substance NICOTINE
Active strength 4 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 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 A090711-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 A090711-002 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10
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.
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 2026-08-01 22:54:32 2026-06 A090711-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 a50c72e98297…2026-08-01 22:54:32 2026-06 A090711-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2009-07-10 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 2 · 29 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base nicotine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 4 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 359818 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41250-190-03 nicotine 24 in 1 CONTAINER LOZENGE 24 9 41250-190-05 nicotine 3 in 1 CARTON LOZENGE 3 9 41250-190-09 nicotine 27 in 1 CONTAINER LOZENGE 27 9 41250-190-10 nicotine 4 in 1 CARTON LOZENGE 4 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-190 NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC] 7 Current NDC, Legacy NDC, 4 package rows 20250425_18ee7d8b-7b18-404e-8e62-c10355bb0a26.zip
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 41250-190-03 41250019003 24 in 1 CONTAINER Historical 41250-190-05 41250019005 3 CONTAINER in 1 CARTON (41250-190-05) / 24 LOZENGE in 1 CONTAINER (41250-190-03) 3 container 2009-09-16 0000-00-00 No No Current 41250-190-09 41250019009 27 in 1 CONTAINER Historical 41250-190-10 41250019010 4 CONTAINER in 1 CARTON (41250-190-10) / 27 LOZENGE in 1 CONTAINER (41250-190-09) 4 container 2026-04-07 No No Current