FDA.reportPublic FDA data

AMAZON BASIC CARE NICOTINE POLACRILEX

Product NDC
72288-623
11-digit product format
722880623
Labeler code
72288
Product ID
72288-623_b5c2eb67-9d0b-4272-9730-44a4f3d4c7c6
Type
HUMAN OTC DRUG
Nonproprietary name
NICOTINE POLACRILEX
Dosage form
LOZENGE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA213266
Marketing category
ANDA
Marketing start
2024-05-15
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
AMAZON BASIC CARE NICOTINE POLACRILEX
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
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
72288-623-14AMAZON BASIC CARE NICOTINE POLACRILEX24 in 1 CONTAINERLOZENGE244
72288-623-14AMAZON BASIC CARE NICOTINE POLACRILEX6 in 1 CARTONLOZENGE64
72288-623-21AMAZON BASIC CARE NICOTINE POLACRILEX24 in 1 CONTAINERLOZENGE244
72288-623-21AMAZON BASIC CARE NICOTINE POLACRILEX9 in 1 CARTONLOZENGE94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-623AMAZON BASIC CARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMAZON.COM SERVICES LLC]4Current NDC, 4 package rows20250503_113e0be9-7edc-4766-e063-6294a90af752.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN113e0be9-7edc-4766-e063-6294a90af7524
359817nicotine 2 MG Oral LozengeSCD113e0be9-7edc-4766-e063-6294a90af7524
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY113e0be9-7edc-4766-e063-6294a90af7524
359817nicotine 2 MG TrocheSY113e0be9-7edc-4766-e063-6294a90af7524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-623-14722880623146 CONTAINER in 1 CARTON (72288-623-14) / 24 LOZENGE in 1 CONTAINER6 container2024-05-15NoNoCurrent
72288-623-21722880623219 CONTAINER in 1 CARTON (72288-623-21) / 24 LOZENGE in 1 CONTAINER9 container2024-05-15NoNoCurrent