FDA.reportPublic FDA data

Nicotine

Product NDC
46122-732
11-digit product format
461220732
Labeler code
46122
Product ID
46122-732_8236245e-bb7e-45c6-81ee-5bd01587436b
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
AmerisourceBergen (Good Neighbor Pharmacy) 46122
Application
ANDA209206
Marketing category
ANDA
Marketing start
2023-02-24
Marketing end
2027-10-28
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

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-732-08Nicotine3 in 1 BOXLOZENGE35
46122-732-08Nicotine24 in 1 BOTTLE, PLASTICLOZENGE245
46122-732-62Nicotine24 in 1 BOTTLE, PLASTICLOZENGE245
46122-732-62Nicotine1 in 1 BOXLOZENGE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-732-08EA - Each46122-7328fa8711e-9484-493c-a447-99f98b233f8212023-05-05
46122-732-62EA - Each46122-732d8338d1b-155f-47d9-84ed-0d4351f9fd7912024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-732NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]4Current NDC, Legacy NDC, 4 package rows20250331_39640129-2d7a-4ec5-81a1-e14b11d3d3ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN39640129-2d7a-4ec5-81a1-e14b11d3d3ee5
359818nicotine 4 MG Oral LozengeSCD39640129-2d7a-4ec5-81a1-e14b11d3d3ee5
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY39640129-2d7a-4ec5-81a1-e14b11d3d3ee5
359818nicotine 4 MG TrocheSY39640129-2d7a-4ec5-81a1-e14b11d3d3ee5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-732-08461220732083 BOTTLE, PLASTIC in 1 BOX (46122-732-08) / 24 LOZENGE in 1 BOTTLE, PLASTIC2023-02-242027-10-28NoNoCurrent
46122-732-62461220732621 BOTTLE, PLASTIC in 1 BOX (46122-732-62) / 24 LOZENGE in 1 BOTTLE, PLASTIC2023-02-242027-10-28NoNoCurrent