FDA.reportPublic FDA data

nicotine

Product NDC
41250-700
11-digit product format
412500700
Labeler code
41250
Product ID
41250-700_352fb71d-be46-4d6f-a70d-c42db3e2276a
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA090711
Marketing category
ANDA
Marketing start
2009-09-11
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
nicotine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-700-03nicotine24 in 1 CONTAINERLOZENGE248
41250-700-05nicotine3 in 1 CARTONLOZENGE38
41250-700-09nicotine27 in 1 CONTAINERLOZENGE278
41250-700-10nicotine4 in 1 CARTONLOZENGE48

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-700NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER DISTRIBUTION INC]6Current NDC, Legacy NDC, 4 package rows20250430_3566423d-3ddb-4913-9da5-fb43680f0efc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN3566423d-3ddb-4913-9da5-fb43680f0efc8
359817nicotine 2 MG Oral LozengeSCD3566423d-3ddb-4913-9da5-fb43680f0efc8
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY3566423d-3ddb-4913-9da5-fb43680f0efc8
359817nicotine 2 MG TrocheSY3566423d-3ddb-4913-9da5-fb43680f0efc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-700-034125007000324 in 1 CONTAINERHistorical
41250-700-05412500700053 CONTAINER in 1 CARTON (41250-700-05) / 24 LOZENGE in 1 CONTAINER (41250-700-03) 3 container2009-09-110000-00-00NoNoCurrent
41250-700-094125007000927 in 1 CONTAINERHistorical
41250-700-10412500700104 CONTAINER in 1 CARTON (41250-700-10) / 27 LOZENGE in 1 CONTAINER (41250-700-09) 4 container2026-04-07NoNoCurrent