FDA.reportPublic FDA data

Nicotine

Product NDC
69842-858
11-digit product format
698420858
Labeler code
69842
Product ID
69842-858_13b0ddbb-8a3d-4a4f-819b-97d7a70d4cde
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA209206
Marketing category
ANDA
Marketing start
2019-04-30
Marketing end
2026-12-30
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Brand name suffix
Sugar Free

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
69842-858-24NicotineSugar Free24 in 1 BOTTLE, PLASTICLOZENGE246
69842-858-24NicotineSugar Free1 in 1 BOXLOZENGE16
69842-858-48NicotineSugar Free24 in 1 BOTTLE, PLASTICLOZENGE246
69842-858-48NicotineSugar Free2 in 1 BOXLOZENGE26
69842-858-68NicotineSugar Free24 in 1 BOTTLE, PLASTICLOZENGE246
69842-858-68NicotineSugar Free7 in 1 BOXLOZENGE76
69842-858-96NicotineSugar Free24 in 1 BOTTLE, PLASTICLOZENGE246
69842-858-96NicotineSugar Free4 in 1 BOXLOZENGE46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-858NICOTINE SUGAR FREE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]5Current NDC, Legacy NDC, 8 package rows20221124_a275ff04-4078-4783-932b-dde9aee04682.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNa275ff04-4078-4783-932b-dde9aee046826
359818nicotine 4 MG Oral LozengeSCDa275ff04-4078-4783-932b-dde9aee046826
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYa275ff04-4078-4783-932b-dde9aee046826
359818nicotine 4 MG TrocheSYa275ff04-4078-4783-932b-dde9aee046826

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-858-24698420858241 BOTTLE, PLASTIC in 1 BOX (69842-858-24) / 24 LOZENGE in 1 BOTTLE, PLASTIC2019-04-302026-12-30NoNoCurrent
69842-858-48698420858482 BOTTLE, PLASTIC in 1 BOX (69842-858-48) / 24 LOZENGE in 1 BOTTLE, PLASTIC2019-04-302026-12-30NoNoCurrent
69842-858-68698420858687 BOTTLE, PLASTIC in 1 BOX (69842-858-68) / 24 LOZENGE in 1 BOTTLE, PLASTIC2019-04-302026-12-30NoNoCurrent
69842-858-96698420858964 BOTTLE, PLASTIC in 1 BOX (69842-858-96) / 24 LOZENGE in 1 BOTTLE, PLASTIC2019-04-302026-12-30NoNoCurrent