careone childrens allergy relief

Product NDC
41520-716
11-digit product format
415200716
Labeler code
41520
Product ID
41520-716_567de4c6-c106-4597-9e1a-f43fbb1592d6
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
American Sales Company
Application
ANDA210033
Marketing category
ANDA
Marketing start
2019-07-16
Substance
LORATADINE
Active strength
5 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
careone childrens allergy relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui665078

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-716-01careone childrens allergy relief20 in 1 CARTONTABLET, CHEWABLE202
41520-716-01careone childrens allergy relief1 in 1 BLISTER PACKTABLET, CHEWABLE12
41520-716-39careone childrens allergy relief1 in 1 BLISTER PACKTABLET, CHEWABLE12
41520-716-39careone childrens allergy relief30 in 1 CARTONTABLET, CHEWABLE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-716CAREONE CHILDRENS ALLERGY RELIEF (LORATADINE) TABLET, CHEWABLE [AMERICAN SALES COMPANY]2Current NDC, Legacy NDC, 4 package rows20200820_06d1c443-ec23-4aa1-a7f3-f2b7ffcc2588.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN06d1c443-ec23-4aa1-a7f3-f2b7ffcc25882
665078loratadine 5 MG Chewable TabletSCD06d1c443-ec23-4aa1-a7f3-f2b7ffcc25882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-716-014152007160120 BLISTER PACK in 1 CARTON (41520-716-01) / 1 TABLET, CHEWABLE in 1 BLISTER PACK20 blister pack2019-07-190000-00-00NoNoCurrent
41520-716-394152007163930 BLISTER PACK in 1 CARTON (41520-716-39) / 1 TABLET, CHEWABLE in 1 BLISTER PACK30 blister pack2019-07-160000-00-00NoNoCurrent