FDA.reportPublic FDA data

NICOTINE

Product NDC
58602-835
11-digit product format
586020835
Labeler code
58602
Product ID
58602-835_bc65a833-389c-4726-9c08-e10e03ef7bf7
Type
HUMAN OTC DRUG
Nonproprietary name
NICOTINE POLACRILEX
Dosage form
LOZENGE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA213266
Marketing category
ANDA
Marketing start
2021-08-03
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
58602-835-07NICOTINE1 in 1 CARTONLOZENGE13
58602-835-07NICOTINE24 in 1 CONTAINERLOZENGE243
58602-835-51NICOTINE3 in 1 CARTONLOZENGE33
58602-835-51NICOTINE24 in 1 CONTAINERLOZENGE243
58602-835-52NICOTINE4 in 1 CARTONLOZENGE43
58602-835-52NICOTINE24 in 1 CONTAINERLOZENGE243
58602-835-65NICOTINE6 in 1 CARTONLOZENGE63
58602-835-65NICOTINE24 in 1 CONTAINERLOZENGE243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-835NICOTINE (NICOTINE POLACRILEX) LOZENGE [AUROHEALTH LLC]3Current NDC, Legacy NDC, 8 package rows20220311_fa730ae3-c2b3-4ea4-8e50-f819b205d168.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNfa730ae3-c2b3-4ea4-8e50-f819b205d1683
359817nicotine 2 MG Oral LozengeSCDfa730ae3-c2b3-4ea4-8e50-f819b205d1683
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYfa730ae3-c2b3-4ea4-8e50-f819b205d1683
359817nicotine 2 MG TrocheSYfa730ae3-c2b3-4ea4-8e50-f819b205d1683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-835-07586020835071 CONTAINER in 1 CARTON (58602-835-07) / 24 LOZENGE in 1 CONTAINER1 container2021-08-030000-00-00NoNoCurrent
58602-835-51586020835513 CONTAINER in 1 CARTON (58602-835-51) / 24 LOZENGE in 1 CONTAINER3 container2021-08-030000-00-00NoNoCurrent
58602-835-52586020835524 CONTAINER in 1 CARTON (58602-835-52) / 24 LOZENGE in 1 CONTAINER4 container2021-08-030000-00-00NoNoCurrent
58602-835-65586020835656 CONTAINER in 1 CARTON (58602-835-65) / 24 LOZENGE in 1 CONTAINER6 container2021-08-030000-00-00NoNoCurrent