Nicotine Mini

Product NDC
83253-262
11-digit product format
832530262
Labeler code
83253
Product ID
83253-262_c565e821-f541-44aa-9244-2f5b12923f28
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
HC Jones, Inc.
Application
ANDA207868
Marketing category
ANDA
Marketing start
2023-04-30
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 Mini
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
83253-262-27Nicotine Mini27 in 1 BOTTLE, PLASTICLOZENGE277
83253-262-81Nicotine Mini27 in 1 BOTTLE, PLASTICLOZENGE277
83253-262-81Nicotine Mini3 in 1 BOTTLELOZENGE37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83253-262NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [HC JONES, INC.]3Current NDC, 3 package rows20250326_d0d1a5ef-fd4c-4854-9453-68808cc0fab0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNd0d1a5ef-fd4c-4854-9453-68808cc0fab07
359817nicotine 2 MG Oral LozengeSCDd0d1a5ef-fd4c-4854-9453-68808cc0fab07
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYd0d1a5ef-fd4c-4854-9453-68808cc0fab07
359817nicotine 2 MG TrocheSYd0d1a5ef-fd4c-4854-9453-68808cc0fab07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83253-262-278325302622727 LOZENGE in 1 BOTTLE, PLASTIC (83253-262-27) 27 lozenge2023-04-30NoNoCurrent
83253-262-81832530262813 BOTTLE, PLASTIC in 1 BOTTLE (83253-262-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC2023-04-30NoNoCurrent