FDA.reportPublic FDA data

Nicotine

Product NDC
83253-978
11-digit product format
832530978
Labeler code
83253
Product ID
83253-978_5139e102-27df-4d31-ab96-0bdac80ec058
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
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
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
83253-978-27Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277
83253-978-72Nicotine1 in 1 BOXLOZENGE17
83253-978-72Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277
83253-978-81Nicotine3 in 1 BOXLOZENGE37
83253-978-81Nicotine27 in 1 BOTTLE, PLASTICLOZENGE277

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83253-978NICOTINE (NICOTINE POLACRILEX) LOZENGE [HC JONES, INC.]2Current NDC, 5 package rows20250331_e07226e8-3be4-46e4-aa4f-c5d88db1ccfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNe07226e8-3be4-46e4-aa4f-c5d88db1ccfa7
359817nicotine 2 MG Oral LozengeSCDe07226e8-3be4-46e4-aa4f-c5d88db1ccfa7
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYe07226e8-3be4-46e4-aa4f-c5d88db1ccfa7
359817nicotine 2 MG TrocheSYe07226e8-3be4-46e4-aa4f-c5d88db1ccfa7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83253-978-278325309782727 LOZENGE in 1 BOTTLE, PLASTIC (83253-978-27) 27 lozenge2025-03-31NoNoCurrent
83253-978-72832530978721 BOTTLE, PLASTIC in 1 BOX (83253-978-72) / 27 LOZENGE in 1 BOTTLE, PLASTIC2025-03-31NoNoCurrent
83253-978-81832530978813 BOTTLE, PLASTIC in 1 BOX (83253-978-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC2025-03-31NoNoCurrent