FDA.reportPublic FDA data

Nicotine

Product NDC
59779-397
11-digit product format
597790397
Labeler code
59779
Product ID
59779-397_f8fcf4fe-2c57-4c18-a799-c5ba8bc0c998
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA090711
Marketing category
ANDA
Marketing start
1998-06-23
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
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
59779-397-03Nicotine1 in 1 CARTONLOZENGE110
59779-397-03Nicotine24 in 1 CONTAINERLOZENGE2410
59779-397-05Nicotine24 in 1 CONTAINERLOZENGE2410
59779-397-05Nicotine3 in 1 CARTONLOZENGE310
59779-397-06Nicotine4 in 1 CARTONLOZENGE410
59779-397-06Nicotine24 in 1 CONTAINERLOZENGE2410
59779-397-09Nicotine27 in 1 CONTAINERLOZENGE2710
59779-397-10Nicotine4 in 1 CARTONLOZENGE410
59779-397-11Nicotine24 in 1 CONTAINERLOZENGE2410
59779-397-11Nicotine7 in 1 CARTONLOZENGE710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-397NICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]10Current NDC, Legacy NDC, 10 package rows20240711_5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b210
359817nicotine 2 MG Oral LozengeSCD5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b210
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b210
359817nicotine 2 MG TrocheSY5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-397-03597790397031 CONTAINER in 1 CARTON (59779-397-03) > 24 LOZENGE in 1 CONTAINER1 container2019-08-260000-00-00NoNoCurrent
59779-397-05597790397053 CONTAINER in 1 CARTON (59779-397-05) > 24 LOZENGE in 1 CONTAINER3 container2009-10-010000-00-00NoNoCurrent
59779-397-06597790397064 CONTAINER in 1 CARTON (59779-397-06) > 24 LOZENGE in 1 CONTAINER4 container2011-10-190000-00-00NoNoCurrent
59779-397-095977903970927 in 1 CONTAINERHistorical
59779-397-10597790397104 CONTAINER in 1 CARTON (59779-397-10) / 27 LOZENGE in 1 CONTAINER (59779-397-09) 4 container2024-07-03NoNoCurrent
59779-397-11597790397117 CONTAINER in 1 CARTON (59779-397-11) > 24 LOZENGE in 1 CONTAINER7 container2015-06-110000-00-00NoNoCurrent