Nicotine Mini

Product NDC
59726-652
11-digit product format
597260652
Labeler code
59726
Product ID
59726-652_f0d20091-8736-49dd-93d7-3b6767888144
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
P & L Development, LLC
Application
ANDA210711
Marketing category
ANDA
Marketing start
2025-06-01
Substance
NICOTINE
Active strength
4 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 Mini
Listing expiration
2026-12-31

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
59726-652-04Nicotine Mini27 in 1 BOTTLE, PLASTICLOZENGE272
59726-652-04Nicotine Mini5 in 1 BOXLOZENGE52
59726-652-27Nicotine Mini27 in 1 BOTTLE, PLASTICLOZENGE272
59726-652-27Nicotine Mini1 in 1 BOXLOZENGE12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN3623455a-3f00-41d3-b17e-86a016da70472
359818nicotine 4 MG Oral LozengeSCD3623455a-3f00-41d3-b17e-86a016da70472
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY3623455a-3f00-41d3-b17e-86a016da70472
359818nicotine 4 MG TrocheSY3623455a-3f00-41d3-b17e-86a016da70472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59726-652-04597260652045 BOTTLE, PLASTIC in 1 BOX (59726-652-04) / 27 LOZENGE in 1 BOTTLE, PLASTIC2025-06-01NoNoCurrent
59726-652-27597260652271 BOTTLE, PLASTIC in 1 BOX (59726-652-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC2025-06-01NoNoCurrent