Nicotine Mini

Product NDC
17856-1239
11-digit product format
178561239
Labeler code
17856
Product ID
17856-1239_3892ec29-4780-195e-e063-6394a90a1413
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA207868
Marketing category
ANDA
Marketing start
2019-07-31
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-1239-12024-05-08C16284748780-11030e365-1654-111a-e063-dadaa90a10e2Drug Facts
17856-1239-12024-01-30C16284748780-11030e365-1654-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1239-1Nicotine Mini50 in 1 BOX, UNIT-DOSELOZENGE505
17856-1239-2Nicotine Mini1 in 1 POUCHLOZENGE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1239NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [ATLANTIC BIOLOGICALS CORP.]4Current NDC, Legacy NDC, 2 package rows20240509_31e0dadd-2678-4e3c-9e62-e3766c21ce5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN31e0dadd-2678-4e3c-9e62-e3766c21ce5f5
359817nicotine 2 MG Oral LozengeSCD31e0dadd-2678-4e3c-9e62-e3766c21ce5f5
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY31e0dadd-2678-4e3c-9e62-e3766c21ce5f5
359817nicotine 2 MG TrocheSY31e0dadd-2678-4e3c-9e62-e3766c21ce5f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-1239-11785612390150 POUCH in 1 BOX, UNIT-DOSE (17856-1239-1) / 1 LOZENGE in 1 POUCH (17856-1239-2) 50 pouch2024-05-080000-00-00NoNoCurrent
17856-1239-2178561239021 in 1 POUCHHistorical