Mini Nicotine

Product NDC
17856-1241
11-digit product format
178561241
Labeler code
17856
Product ID
17856-1241_3892fb10-9e99-9058-e063-6294a90a26b8
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
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
Mini Nicotine
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-1241-12024-05-08C16284748780-11030e364-fc80-111a-e063-dadaa90a10e2Drug Facts
17856-1241-12024-01-30C16284748780-11030e364-fc80-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1241-1Mini Nicotine50 in 1 BOXLOZENGE503
17856-1241-2Mini Nicotine1 in 1 POUCHLOZENGE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1241MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [ATLANTIC BIOLOGICALS CORP.]2Current NDC, Legacy NDC, 2 package rows20240509_a0fc3eae-9c34-48af-bdd2-d95e91b68a9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNa0fc3eae-9c34-48af-bdd2-d95e91b68a9c3
359818nicotine 4 MG Oral LozengeSCDa0fc3eae-9c34-48af-bdd2-d95e91b68a9c3
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYa0fc3eae-9c34-48af-bdd2-d95e91b68a9c3
359818nicotine 4 MG TrocheSYa0fc3eae-9c34-48af-bdd2-d95e91b68a9c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-1241-11785612410150 POUCH in 1 BOX (17856-1241-1) / 1 LOZENGE in 1 POUCH (17856-1241-2) 50 pouch2024-05-080000-00-00NoNoCurrent
17856-1241-2178561241021 in 1 POUCHHistorical