FDA.reportPublic FDA data

Mini Nicotine

Product NDC
79481-0223
11-digit product format
794810223
Labeler code
79481
Product ID
79481-0223_ececbc97-9e8c-478d-aba5-c5341f864b02
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA203690
Marketing category
ANDA
Marketing start
2024-05-09
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
Mini 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
79481-0223-1Mini Nicotine1 in 1 CARTONLOZENGE14
79481-0223-1Mini Nicotine27 in 1 CONTAINERLOZENGE274
79481-0223-2Mini Nicotine3 in 1 CARTONLOZENGE34
79481-0223-2Mini Nicotine27 in 1 CONTAINERLOZENGE274

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0223MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER, INC.]2Current NDC, 4 package rows20240522_2da4cfb9-2b8d-4465-adf5-edd52671b9fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN2da4cfb9-2b8d-4465-adf5-edd52671b9fc4
359817nicotine 2 MG Oral LozengeSCD2da4cfb9-2b8d-4465-adf5-edd52671b9fc4
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY2da4cfb9-2b8d-4465-adf5-edd52671b9fc4
359817nicotine 2 MG TrocheSY2da4cfb9-2b8d-4465-adf5-edd52671b9fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0223-1794810223011 CONTAINER in 1 CARTON (79481-0223-1) / 27 LOZENGE in 1 CONTAINER1 container2024-05-09NoNoHistorical
79481-0223-2794810223023 CONTAINER in 1 CARTON (79481-0223-2) / 27 LOZENGE in 1 CONTAINER3 container2024-05-09NoNoHistorical