FDA.reportPublic FDA data

Nicotine

Product NDC
69842-662
11-digit product format
698420662
Labeler code
69842
Product ID
69842-662_96082784-950d-4144-add7-1f4bd7d5a4eb
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA207868
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Brand name suffix
Sugar Free
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
69842-662-10NicotineSugar Free10 in 1 BOTTLE, PLASTICLOZENGE106
69842-662-10NicotineSugar Free1 in 1 BOXLOZENGE16
69842-662-20NicotineSugar Free1 in 1 BOXLOZENGE16
69842-662-20NicotineSugar Free20 in 1 BOTTLE, PLASTICLOZENGE206
69842-662-27NicotineSugar Free27 in 1 BOTTLE, PLASTICLOZENGE276
69842-662-27NicotineSugar Free1 in 1 BOXLOZENGE16
69842-662-35NicotineSugar Free27 in 1 BOTTLE, PLASTICLOZENGE276
69842-662-35NicotineSugar Free5 in 1 BOXLOZENGE56
69842-662-81NicotineSugar Free27 in 1 BOTTLE, PLASTICLOZENGE276
69842-662-81NicotineSugar Free3 in 1 BOXLOZENGE36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-662NICOTINE SUGAR FREE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4Current NDC, Legacy NDC, 10 package rows20221123_9a96ba38-e696-4465-9869-9b269dc18f8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN9a96ba38-e696-4465-9869-9b269dc18f8d6
359817nicotine 2 MG Oral LozengeSCD9a96ba38-e696-4465-9869-9b269dc18f8d6
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY9a96ba38-e696-4465-9869-9b269dc18f8d6
359817nicotine 2 MG TrocheSY9a96ba38-e696-4465-9869-9b269dc18f8d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-662-10698420662101 BOTTLE, PLASTIC in 1 BOX (69842-662-10) / 10 LOZENGE in 1 BOTTLE, PLASTIC2020-05-290000-00-00NoNoCurrent
69842-662-20698420662201 BOTTLE, PLASTIC in 1 BOX (69842-662-20) / 20 LOZENGE in 1 BOTTLE, PLASTIC2020-05-290000-00-00NoNoCurrent
69842-662-27698420662271 BOTTLE, PLASTIC in 1 BOX (69842-662-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-05-290000-00-00NoNoCurrent
69842-662-35698420662355 BOTTLE, PLASTIC in 1 BOX (69842-662-35) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-05-290000-00-00NoNoCurrent
69842-662-81698420662813 BOTTLE, PLASTIC in 1 BOX (69842-662-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-05-290000-00-00NoNoCurrent