FDA.reportPublic FDA data

Nicotine

Product NDC
46122-734
11-digit product format
461220734
Labeler code
46122
Product ID
46122-734_5233c7da-004e-4b4e-a78f-5225df1447ec
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
2023-02-23
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
46122-734-08Nicotine3 in 1 BOXLOZENGE35
46122-734-08Nicotine24 in 1 BOTTLE, PLASTICLOZENGE245
46122-734-62Nicotine24 in 1 BOTTLE, PLASTICLOZENGE245

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-734-08EA - Each46122-734a0b7bb9b-67ec-4546-935b-69ac000d2e1912023-05-05
46122-734-62EA - Each46122-7348161b1cd-5f23-400e-b499-1534ffc6fd6b12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-734NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]5Current NDC, Legacy NDC, 3 package rows20250331_a33b6ed6-2c75-4bab-98e5-a7f8bea21926.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNa33b6ed6-2c75-4bab-98e5-a7f8bea219265
359817nicotine 2 MG Oral LozengeSCDa33b6ed6-2c75-4bab-98e5-a7f8bea219265
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYa33b6ed6-2c75-4bab-98e5-a7f8bea219265
359817nicotine 2 MG TrocheSYa33b6ed6-2c75-4bab-98e5-a7f8bea219265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-734-08461220734083 BOTTLE, PLASTIC in 1 BOX (46122-734-08) / 24 LOZENGE in 1 BOTTLE, PLASTIC2023-02-230000-00-00NoNoCurrent
46122-734-624612207346224 LOZENGE in 1 BOTTLE, PLASTIC (46122-734-62) 24 lozenge2023-02-230000-00-00NoNoCurrent