First Aid Direct Allergy Relief

Product NDC
42961-120
11-digit product format
429610120
Labeler code
42961
Product ID
42961-120_698cf169-c537-491e-9e70-b920b627761e
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine Tablets
Dosage form
TABLET
Route
ORAL
Labeler
Cintas Corporation
Application
ANDA210722
Marketing category
ANDA
Marketing start
2021-10-20
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
First Aid Direct 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
42961-120-02First Aid Direct Allergy Relief2 in 1 BOXTABLET22
42961-120-02First Aid Direct Allergy Relief10 in 1 BLISTER PACKTABLET102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-120FIRST AID DIRECT ALLERGY RELIEF (LORATADINE TABLETS) TABLET [CINTAS CORPORATION]1Current NDC, Legacy NDC, 2 package rows20220825_6b43e5a5-30a8-46ca-a44d-1e1abf567b51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN6b43e5a5-30a8-46ca-a44d-1e1abf567b512
311372loratadine 10 MG Oral TabletSCD6b43e5a5-30a8-46ca-a44d-1e1abf567b512
311372loratadine 10 MG 24 HR Oral TabletSY6b43e5a5-30a8-46ca-a44d-1e1abf567b512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42961-120-02429610120022 BLISTER PACK in 1 BOX (42961-120-02) / 10 TABLET in 1 BLISTER PACK2 blister pack2021-10-200000-00-00NoNoCurrent