FDA.reportPublic FDA data

Nicotine

Product NDC
69842-957
11-digit product format
698420957
Labeler code
69842
Product ID
69842-957_848d350b-189e-44c5-aaea-a4fceb427986
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA209206
Marketing category
ANDA
Marketing start
2020-05-29
Marketing end
2026-12-29
Substance
NICOTINE
Active strength
2 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
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
69842-957-24NicotineSugar Free24 in 1 BOTTLE, PLASTICLOZENGE246
69842-957-24NicotineSugar Free1 in 1 BOXLOZENGE16
69842-957-48NicotineSugar Free1 in 1 BOXLOZENGE16
69842-957-48NicotineSugar Free48 in 1 BOTTLE, PLASTICLOZENGE486
69842-957-68NicotineSugar Free24 in 1 BOTTLE, PLASTICLOZENGE246
69842-957-68NicotineSugar Free7 in 1 BOXLOZENGE76
69842-957-96NicotineSugar Free4 in 1 BOXLOZENGE46
69842-957-96NicotineSugar Free24 in 1 BOTTLE, PLASTICLOZENGE246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-957NICOTINE SUGAR FREE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]5Current NDC, Legacy NDC, 8 package rows20221123_63fce25d-457f-4048-86a4-1805f603936c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN63fce25d-457f-4048-86a4-1805f603936c6
359817nicotine 2 MG Oral LozengeSCD63fce25d-457f-4048-86a4-1805f603936c6
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY63fce25d-457f-4048-86a4-1805f603936c6
359817nicotine 2 MG TrocheSY63fce25d-457f-4048-86a4-1805f603936c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-957-24698420957241 BOTTLE, PLASTIC in 1 BOX (69842-957-24) / 24 LOZENGE in 1 BOTTLE, PLASTIC2020-05-292026-12-29NoNoCurrent
69842-957-48698420957481 BOTTLE, PLASTIC in 1 BOX (69842-957-48) / 48 LOZENGE in 1 BOTTLE, PLASTIC2020-05-292026-12-29NoNoCurrent
69842-957-68698420957687 BOTTLE, PLASTIC in 1 BOX (69842-957-68) / 24 LOZENGE in 1 BOTTLE, PLASTIC2020-05-292026-12-29NoNoCurrent
69842-957-96698420957964 BOTTLE, PLASTIC in 1 BOX (69842-957-96) / 24 LOZENGE in 1 BOTTLE, PLASTIC2020-05-292026-12-29NoNoCurrent