FDA.reportPublic FDA data

Nicotine

Product NDC
69842-932
11-digit product format
698420932
Labeler code
69842
Product ID
69842-932_cd8872c7-4512-446a-9676-ec16c786e9fc
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA210711
Marketing category
ANDA
Marketing start
2020-05-29
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Brand name suffix
Sugar Free
Listing expiration
2026-12-31

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
69842-932-08NicotineSugar Free27 in 1 BOTTLE, PLASTICLOZENGE272
69842-932-08NicotineSugar Free4 in 1 BOXLOZENGE42
69842-932-27NicotineSugar Free1 in 1 BOXLOZENGE12
69842-932-27NicotineSugar Free27 in 1 BOTTLE, PLASTICLOZENGE272
69842-932-89NicotineSugar Free7 in 1 BOXLOZENGE72
69842-932-89NicotineSugar Free27 in 1 BOTTLE, PLASTICLOZENGE272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-932NICOTINE SUGAR FREE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]2Current NDC, 6 package rows20231223_8986c712-6399-450e-8178-01fef29ebc52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN8986c712-6399-450e-8178-01fef29ebc522
359817nicotine 2 MG Oral LozengeSCD8986c712-6399-450e-8178-01fef29ebc522
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY8986c712-6399-450e-8178-01fef29ebc522
359817nicotine 2 MG TrocheSY8986c712-6399-450e-8178-01fef29ebc522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69842-932-08698420932084 BOTTLE, PLASTIC in 1 BOX (69842-932-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-05-29NoNoHistorical
69842-932-27698420932271 BOTTLE, PLASTIC in 1 BOX (69842-932-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-05-29NoNoHistorical
69842-932-89698420932897 BOTTLE, PLASTIC in 1 BOX (69842-932-89) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-05-29NoNoHistorical