FDA.reportPublic FDA data

CareOne Allergy Relief

Product NDC
41520-612
11-digit product format
415200612
Labeler code
41520
Product ID
41520-612_018a3e2f-e1c3-4fc9-82e5-0bde04555116
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
American Sales Company
Application
ANDA076301
Marketing category
ANDA
Marketing start
2006-06-02
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
CareOne Allergy Relief
Brand name suffix
24 Hour
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
41520-612-03CareOne Allergy Relief24 Hour70 in 1 BOTTLETABLET7012
41520-612-03CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-46CareOne Allergy Relief24 Hour1 in 1 BLISTER PACKTABLET112
41520-612-46CareOne Allergy Relief24 Hour10 in 1 CARTONTABLET1012
41520-612-58CareOne Allergy Relief24 Hour40 in 1 BOTTLETABLET4012
41520-612-58CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-60CareOne Allergy Relief24 Hour20 in 1 CARTONTABLET2012
41520-612-60CareOne Allergy Relief24 Hour1 in 1 BLISTER PACKTABLET112
41520-612-65CareOne Allergy Relief24 Hour30 in 1 BOTTLETABLET3012
41520-612-65CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-72CareOne Allergy Relief24 Hour60 in 1 BOTTLETABLET6012
41520-612-72CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-75CareOne Allergy Relief24 Hour90 in 1 BOTTLETABLET9012
41520-612-75CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-76CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-76CareOne Allergy Relief24 Hour120 in 1 BOTTLETABLET12012
41520-612-78CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-78CareOne Allergy Relief24 Hour100 in 1 BOTTLETABLET10012
41520-612-82CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-82CareOne Allergy Relief24 Hour200 in 1 BOTTLETABLET20012
41520-612-95CareOne Allergy Relief24 Hour1 in 1 CARTONTABLET112
41520-612-95CareOne Allergy Relief24 Hour45 in 1 BOTTLETABLET4512

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNCAREONE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [AMERICAN SALES COMPANY]6
LORATADINEACTIVE MOIETY7AJO3BO7QNCAREONE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [AMERICAN SALES COMPANY]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCAREONE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [AMERICAN SALES COMPANY]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CAREONE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [AMERICAN SALES COMPANY]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ECAREONE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [AMERICAN SALES COMPANY]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-612CAREONE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [AMERICAN SALES COMPANY]10Current NDC, Legacy NDC, 22 package rows20200319_bbd5424f-fa5b-4955-8542-7011b19400ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNbbd5424f-fa5b-4955-8542-7011b19400ea12
311372loratadine 10 MG Oral TabletSCDbbd5424f-fa5b-4955-8542-7011b19400ea12
311372loratadine 10 MG 24 HR Oral TabletSYbbd5424f-fa5b-4955-8542-7011b19400ea12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-612-03415200612031 BOTTLE in 1 CARTON (41520-612-03) / 70 TABLET in 1 BOTTLE1 bottle2014-08-290000-00-00NoNoCurrent
41520-612-464152006124610 BLISTER PACK in 1 CARTON (41520-612-46) / 1 TABLET in 1 BLISTER PACK10 blister pack2006-06-020000-00-00NoNoCurrent
41520-612-58415200612581 BOTTLE in 1 CARTON (41520-612-58) > 40 TABLET in 1 BOTTLE1 bottle2020-02-250000-00-00NoNoCurrent
41520-612-604152006126020 in 1 CARTONHistorical
41520-612-65415200612651 BOTTLE in 1 CARTON (41520-612-65) / 30 TABLET in 1 BOTTLE1 bottle2007-03-280000-00-00NoNoCurrent
41520-612-724152006127260 in 1 BOTTLEHistorical
41520-612-75415200612751 BOTTLE in 1 CARTON (41520-612-75) / 90 TABLET in 1 BOTTLE1 bottle2006-06-270000-00-00NoNoCurrent
41520-612-76415200612761 BOTTLE in 1 CARTON (41520-612-76) > 120 TABLET in 1 BOTTLE1 bottle2007-02-270000-00-00NoNoCurrent
41520-612-78415200612781 BOTTLE in 1 CARTON (41520-612-78) / 100 TABLET in 1 BOTTLE1 bottle2025-08-01NoNoCurrent
41520-612-82415200612821 BOTTLE in 1 CARTON (41520-612-82) / 200 TABLET in 1 BOTTLE1 bottle2014-02-250000-00-00NoNoCurrent
41520-612-95415200612951 BOTTLE in 1 CARTON (41520-612-95) > 45 TABLET in 1 BOTTLE1 bottle2014-10-130000-00-00NoNoCurrent