FDA.reportPublic FDA data

Mini Nicotine

Product NDC
79481-0301
11-digit product format
794810301
Labeler code
79481
Product ID
79481-0301_f0cd73e8-a5e1-4f0d-a2e4-b9558831e0f8
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA203690
Marketing category
ANDA
Marketing start
2024-05-17
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mini Nicotine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359818

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
79481-0301-0Mini Nicotine27 in 1 CONTAINERLOZENGE274
79481-0301-0Mini Nicotine1 in 1 CARTONLOZENGE14
79481-0301-1Mini Nicotine27 in 1 CONTAINERLOZENGE274
79481-0301-1Mini Nicotine3 in 1 CARTONLOZENGE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0301MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER, INC.]2Current NDC, 4 package rows20240524_084f9d77-b4ab-4328-8ff4-cdc7523daebe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN084f9d77-b4ab-4328-8ff4-cdc7523daebe4
359818nicotine 4 MG Oral LozengeSCD084f9d77-b4ab-4328-8ff4-cdc7523daebe4
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY084f9d77-b4ab-4328-8ff4-cdc7523daebe4
359818nicotine 4 MG TrocheSY084f9d77-b4ab-4328-8ff4-cdc7523daebe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0301-0794810301001 CONTAINER in 1 CARTON (79481-0301-0) / 27 LOZENGE in 1 CONTAINER1 container2024-05-17NoNoCurrent
79481-0301-1794810301013 CONTAINER in 1 CARTON (79481-0301-1) / 27 LOZENGE in 1 CONTAINER3 container2024-05-20NoNoCurrent