FDA.reportPublic FDA data

Mini Nicotine

Product NDC
79481-0957
11-digit product format
794810957
Labeler code
79481
Product ID
79481-0957_efec470c-4a90-45b4-b688-eee782b41bac
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA203690
Marketing category
ANDA
Marketing start
2025-01-12
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

Additional Listing Data#

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

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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0957-0Mini Nicotine27 in 1 CONTAINERLOZENGE273
79481-0957-1Mini Nicotine20 in 1 CONTAINERLOZENGE203
79481-0957-1Mini Nicotine1 in 1 CARTONLOZENGE13
79481-0957-2Mini Nicotine3 in 1 CARTONLOZENGE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0957MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [MEIJER, INC.]2Current NDC, 4 package rows20250123_a6618365-8483-4a40-b81f-4d581b174372.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNa6618365-8483-4a40-b81f-4d581b1743723
359818nicotine 4 MG Oral LozengeSCDa6618365-8483-4a40-b81f-4d581b1743723
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYa6618365-8483-4a40-b81f-4d581b1743723
359818nicotine 4 MG TrocheSYa6618365-8483-4a40-b81f-4d581b1743723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0957-07948109570027 in 1 CONTAINERHistorical
79481-0957-17948109570120 in 1 CONTAINERHistorical
79481-0957-2794810957023 CONTAINER in 1 CARTON (79481-0957-2) / 27 LOZENGE in 1 CONTAINER (79481-0957-0) 3 container2025-01-12NoNoHistorical