Mini Nicotine

Product NDC
83253-264
11-digit product format
832530264
Labeler code
83253
Product ID
83253-264_cdbc7fac-df96-47c9-9a10-91feab324bd2
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
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
83253-264-27Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277
83253-264-81Mini Nicotine3 in 1 BOXLOZENGE37
83253-264-81Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83253-264MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [HC JONES, INC.]3Current NDC, 3 package rows20250323_ff9e34ff-5086-4e1b-9220-27ac2ac1069c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNff9e34ff-5086-4e1b-9220-27ac2ac1069c7
359818nicotine 4 MG Oral LozengeSCDff9e34ff-5086-4e1b-9220-27ac2ac1069c7
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYff9e34ff-5086-4e1b-9220-27ac2ac1069c7
359818nicotine 4 MG TrocheSYff9e34ff-5086-4e1b-9220-27ac2ac1069c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83253-264-278325302642727 LOZENGE in 1 BOTTLE, PLASTIC (83253-264-27) 27 lozenge2023-04-30NoNoCurrent
83253-264-81832530264813 BOTTLE, PLASTIC in 1 BOX (83253-264-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC2023-04-30NoNoCurrent