FDA.reportPublic FDA data

AMAZON BASIC CARE NICOTINE POLACRILEX

Product NDC
72288-690
11-digit product format
722880690
Labeler code
72288
Product ID
72288-690_781d1fca-5615-490b-87e2-0d0d86b8ac33
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
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
AMAZON BASIC CARE NICOTINE POLACRILEX
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
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
72288-690-21AMAZON BASIC CARE NICOTINE POLACRILEX8 in 1 CONTAINERLOZENGE84
72288-690-21AMAZON BASIC CARE NICOTINE POLACRILEX27 in 1 CONTAINERLOZENGE274
72288-690-83AMAZON BASIC CARE NICOTINE POLACRILEX1 in 1 CARTONLOZENGE14
72288-690-83AMAZON BASIC CARE NICOTINE POLACRILEX27 in 1 CONTAINERLOZENGE274
72288-690-85AMAZON BASIC CARE NICOTINE POLACRILEX5 in 1 CARTONLOZENGE54
72288-690-85AMAZON BASIC CARE NICOTINE POLACRILEX27 in 1 CONTAINERLOZENGE274

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-690AMAZON BASIC CARE NICOTINE POLACRILEX (NICOTINE POLACRILEX MINI) LOZENGE [AMAZON.COM SERVICES LLC]4Current NDC, 6 package rows20250503_113e54e3-e9c3-4949-e063-6394a90a6fdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN113e54e3-e9c3-4949-e063-6394a90a6fdf4
359818nicotine 4 MG Oral LozengeSCD113e54e3-e9c3-4949-e063-6394a90a6fdf4
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY113e54e3-e9c3-4949-e063-6394a90a6fdf4
359818nicotine 4 MG TrocheSY113e54e3-e9c3-4949-e063-6394a90a6fdf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-690-21722880690218 CONTAINER in 1 CONTAINER (72288-690-21) / 27 LOZENGE in 1 CONTAINER8 container2024-05-15NoNoCurrent
72288-690-83722880690831 CONTAINER in 1 CARTON (72288-690-83) / 27 LOZENGE in 1 CONTAINER1 container2024-05-15NoNoCurrent
72288-690-85722880690855 CONTAINER in 1 CARTON (72288-690-85) / 27 LOZENGE in 1 CONTAINER5 container2024-05-15NoNoCurrent