FDA.reportPublic FDA data

Nicotine

Product NDC
83253-979
11-digit product format
832530979
Labeler code
83253
Product ID
83253-979_300f7650-5d0a-4131-949e-6f1009493184
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
HC Jones, Inc.
Application
ANDA210711
Marketing category
ANDA
Marketing start
2025-03-31
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
Nicotine
Brand name suffix
Mini
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
83253-979-27NicotineMini27 in 1 BOTTLE, PLASTICLOZENGE279
83253-979-72NicotineMini27 in 1 BOTTLE, PLASTICLOZENGE279
83253-979-72NicotineMini1 in 1 BOXLOZENGE19
83253-979-81NicotineMini3 in 1 BOXLOZENGE39
83253-979-81NicotineMini27 in 1 BOTTLE, PLASTICLOZENGE279

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83253-979NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [HC JONES, INC.]3Current NDC, 5 package rows20250331_80e9ee49-2b38-4b59-80a7-524021bf2b21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN80e9ee49-2b38-4b59-80a7-524021bf2b219
359818nicotine 4 MG Oral LozengeSCD80e9ee49-2b38-4b59-80a7-524021bf2b219
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY80e9ee49-2b38-4b59-80a7-524021bf2b219
359818nicotine 4 MG TrocheSY80e9ee49-2b38-4b59-80a7-524021bf2b219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83253-979-278325309792727 LOZENGE in 1 BOTTLE, PLASTIC (83253-979-27) 27 lozenge2025-03-31NoNoCurrent
83253-979-72832530979721 BOTTLE, PLASTIC in 1 BOX (83253-979-72) / 27 LOZENGE in 1 BOTTLE, PLASTIC2025-03-31NoNoCurrent
83253-979-81832530979813 BOTTLE, PLASTIC in 1 BOX (83253-979-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC2025-03-31NoNoCurrent