FDA.reportPublic FDA data

AMAZON BASIC CARE NICOTINE POLACRILEX

Product NDC
72288-694
11-digit product format
722880694
Labeler code
72288
Product ID
72288-694_f6f030b2-9f07-43ec-8635-8338b6b3d267
Type
HUMAN OTC DRUG
Nonproprietary name
NICOTINE POLACRILEX MINI
Dosage form
LOZENGE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA215357
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
72288-694-21AMAZON BASIC CARE NICOTINE POLACRILEX8 in 1 CARTONLOZENGE84
72288-694-21AMAZON BASIC CARE NICOTINE POLACRILEX27 in 1 CONTAINERLOZENGE274
72288-694-83AMAZON BASIC CARE NICOTINE POLACRILEX1 in 1 CARTONLOZENGE14
72288-694-83AMAZON BASIC CARE NICOTINE POLACRILEX27 in 1 CONTAINERLOZENGE274
72288-694-85AMAZON BASIC CARE NICOTINE POLACRILEX27 in 1 CONTAINERLOZENGE274
72288-694-85AMAZON BASIC CARE NICOTINE POLACRILEX5 in 1 CARTONLOZENGE54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-694AMAZON BASIC CARE NICOTINE POLACRILEX (NICOTINE POLACRILEX MINI) LOZENGE [AMAZON.COM SERVICES LLC]4Current NDC, 6 package rows20250503_10ee6816-8155-d590-e063-6394a90a9dea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN10ee6816-8155-d590-e063-6394a90a9dea4
359817nicotine 2 MG Oral LozengeSCD10ee6816-8155-d590-e063-6394a90a9dea4
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY10ee6816-8155-d590-e063-6394a90a9dea4
359817nicotine 2 MG TrocheSY10ee6816-8155-d590-e063-6394a90a9dea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-694-21722880694218 CONTAINER in 1 CARTON (72288-694-21) / 27 LOZENGE in 1 CONTAINER8 container2024-05-15NoNoCurrent
72288-694-83722880694831 CONTAINER in 1 CARTON (72288-694-83) / 27 LOZENGE in 1 CONTAINER1 container2024-05-15NoNoCurrent
72288-694-85722880694855 CONTAINER in 1 CARTON (72288-694-85) / 27 LOZENGE in 1 CONTAINER5 container2024-05-15NoNoCurrent