FDA.reportPublic FDA data

AMAZON BASIC CARE ALLERGY RELIEF

Product NDC
72288-452
11-digit product format
722880452
Labeler code
72288
Product ID
72288-452_8384bd63-e175-419f-a626-8ae62e23f89d
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA208314
Marketing category
ANDA
Marketing start
2024-05-15
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMAZON BASIC CARE ALLERGY RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-452-09AMAZON BASIC CARE ALLERGY RELIEF30 in 1 BOTTLETABLET303
72288-452-09AMAZON BASIC CARE ALLERGY RELIEF1 in 1 CARTONTABLET13
72288-452-19AMAZON BASIC CARE ALLERGY RELIEF90 in 1 BOTTLETABLET903
72288-452-19AMAZON BASIC CARE ALLERGY RELIEF1 in 1 CARTONTABLET13
72288-452-30AMAZON BASIC CARE ALLERGY RELIEF1 in 1 CARTONTABLET13
72288-452-30AMAZON BASIC CARE ALLERGY RELIEF300 in 1 BOTTLETABLET3003
72288-452-36AMAZON BASIC CARE ALLERGY RELIEF1 in 1 CARTONTABLET13
72288-452-36AMAZON BASIC CARE ALLERGY RELIEF365 in 1 BOTTLETABLET3653
72288-452-70AMAZON BASIC CARE ALLERGY RELIEF70 in 1 BOTTLETABLET703
72288-452-70AMAZON BASIC CARE ALLERGY RELIEF1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-452AMAZON BASIC CARE ALLERGY RELIEF (LORATADINE) TABLET [AMAZON.COM SERVICES LLC]2Current NDC, 10 package rows20240515_113da68e-f658-082a-e063-6294a90ad929.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN113da68e-f658-082a-e063-6294a90ad9293
311372loratadine 10 MG Oral TabletSCD113da68e-f658-082a-e063-6294a90ad9293
311372loratadine 10 MG 24 HR Oral TabletSY113da68e-f658-082a-e063-6294a90ad9293

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-452-09722880452091 BOTTLE in 1 CARTON (72288-452-09) / 30 TABLET in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-452-19722880452191 BOTTLE in 1 CARTON (72288-452-19) / 90 TABLET in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-452-30722880452301 BOTTLE in 1 CARTON (72288-452-30) / 300 TABLET in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-452-36722880452361 BOTTLE in 1 CARTON (72288-452-36) / 365 TABLET in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-452-70722880452701 BOTTLE in 1 CARTON (72288-452-70) / 70 TABLET in 1 BOTTLE1 bottle2026-03-18NoNoCurrent