Nicotine Mini

Product NDC
59726-262
11-digit product format
597260262
Labeler code
59726
Product ID
59726-262_1db909ee-2ae8-4c20-aa75-dc78732811d7
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
P & L Development, LLC
Application
ANDA207868
Marketing category
ANDA
Marketing start
2019-04-01
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 Mini
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-262-35Nicotine Mini27 in 1 BOTTLE, PLASTICLOZENGE275
59726-262-35Nicotine Mini5 in 1 BOXLOZENGE55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-262NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [P & L DEVELOPMENT, LLC]5Current NDC, Legacy NDC, 2 package rows20240131_9ddc3fde-f384-41d2-93d5-077b6e419029.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN9ddc3fde-f384-41d2-93d5-077b6e4190295
359817nicotine 2 MG Oral LozengeSCD9ddc3fde-f384-41d2-93d5-077b6e4190295
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY9ddc3fde-f384-41d2-93d5-077b6e4190295
359817nicotine 2 MG TrocheSY9ddc3fde-f384-41d2-93d5-077b6e4190295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59726-262-35597260262355 BOTTLE, PLASTIC in 1 BOX (59726-262-35) / 27 LOZENGE in 1 BOTTLE, PLASTIC2019-04-010000-00-00NoNoCurrent