Allergy Relief

Product NDC
53117-414
11-digit product format
531170414
Labeler code
53117
Product ID
53117-414_2951457f-e466-43c5-a39e-274c36098613
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine 10mg
Dosage form
TABLET
Route
ORAL
Labeler
First Aid Direct
Application
ANDA210722
Marketing category
ANDA
Marketing start
2020-11-11
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2026-12-31

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
53117-414-85Allergy Relief10 in 1 BLISTER PACKTABLET102
53117-414-85Allergy Relief2 in 1 CARTONTABLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53117-414ALLERGY RELIEF (LORATADINE 10MG) TABLET [FIRST AID DIRECT]2Current NDC, Legacy NDC, 2 package rows20220818_3a580dc7-ff09-462c-9b18-205105349035.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN3a580dc7-ff09-462c-9b18-2051053490352
311372loratadine 10 MG Oral TabletSCD3a580dc7-ff09-462c-9b18-2051053490352
311372loratadine 10 MG 24 HR Oral TabletSY3a580dc7-ff09-462c-9b18-2051053490352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53117-414-85531170414852 BLISTER PACK in 1 CARTON (53117-414-85) / 10 TABLET in 1 BLISTER PACK2 blister pack2020-11-110000-00-00NoNoCurrent