FDA.reportPublic FDA data

Nicotine Mini

Product NDC
0363-0262
11-digit product format
003630262
Labeler code
0363
Product ID
0363-0262_53f29f90-3b59-47f4-b2ab-cde7f34a329d
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Walgreens
Application
ANDA207868
Marketing category
ANDA
Marketing start
2019-08-30
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Mini
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0262-08Nicotine Mini27 in 1 BOTTLE, PLASTICLOZENGE2710
0363-0262-08Nicotine Mini4 in 1 BOXLOZENGE410
0363-0262-20Nicotine Mini20 in 1 BOTTLE, PLASTICLOZENGE2010
0363-0262-20Nicotine Mini1 in 1 BOXLOZENGE110
0363-0262-35Nicotine Mini5 in 1 BOXLOZENGE510
0363-0262-35Nicotine Mini27 in 1 BOTTLE, PLASTICLOZENGE2710
0363-0262-81Nicotine Mini3 in 1 BOTTLELOZENGE310
0363-0262-81Nicotine Mini27 in 1 BOTTLE, PLASTICLOZENGE2710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0262NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [WALGREENS]8Current NDC, Legacy NDC, 8 package rows20241109_60551e9a-c82f-45ce-8ef4-03c00c6c870a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN60551e9a-c82f-45ce-8ef4-03c00c6c870a10
359817nicotine 2 MG Oral LozengeSCD60551e9a-c82f-45ce-8ef4-03c00c6c870a10
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY60551e9a-c82f-45ce-8ef4-03c00c6c870a10
359817nicotine 2 MG TrocheSY60551e9a-c82f-45ce-8ef4-03c00c6c870a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0262-08003630262084 BOTTLE, PLASTIC in 1 BOX (0363-0262-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC2019-08-30NoNoHistorical
0363-0262-20003630262201 BOTTLE, PLASTIC in 1 BOX (0363-0262-20) / 20 LOZENGE in 1 BOTTLE, PLASTIC2019-08-30NoNoHistorical
0363-0262-35003630262355 BOTTLE, PLASTIC in 1 BOX (0363-0262-35) / 27 LOZENGE in 1 BOTTLE, PLASTIC2019-08-300000-00-00NoNoCurrent
0363-0262-81003630262813 BOTTLE, PLASTIC in 1 BOTTLE (0363-0262-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC2019-08-300000-00-00NoNoCurrent