nicotine

Product NDC
41250-201
11-digit product format
412500201
Labeler code
41250
Product ID
41250-201_ba98e47a-d334-4f96-96ab-3b0e622215aa
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polarilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA090821
Marketing category
ANDA
Marketing start
2010-01-15
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-201-03nicotine24 in 1 CONTAINERLOZENGE2410
41250-201-05nicotine3 in 1 CARTONLOZENGE310
41250-201-09nicotine27 in 1 CONTAINERLOZENGE2710
41250-201-10nicotine4 in 1 CARTONLOZENGE410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-201NICOTINE (NICOTINE POLARILEX) LOZENGE [MEIJER DISTRIBUTION INC]8Current NDC, Legacy NDC, 4 package rows20250507_9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d10
359817nicotine 2 MG Oral LozengeSCD9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d10
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d10
359817nicotine 2 MG TrocheSY9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-201-03412500201031 CONTAINER in 1 CARTON (41250-201-03) > 24 LOZENGE in 1 CONTAINER1 container2010-01-150000-00-00NoNoCurrent
41250-201-05412500201053 CONTAINER in 1 CARTON (41250-201-05) / 24 LOZENGE in 1 CONTAINER (41250-201-03) 3 container2010-01-150000-00-00NoNoCurrent
41250-201-094125002010927 in 1 CONTAINERHistorical
41250-201-10412500201104 CONTAINER in 1 CARTON (41250-201-10) / 27 LOZENGE in 1 CONTAINER (41250-201-09) 4 container2026-03-31NoNoCurrent