FDA.reportPublic FDA data

good sense childrens allergy relief

Product NDC
0113-1019
11-digit product format
001131019
Labeler code
0113
Product ID
0113-1019_296442d1-2f06-446d-9265-a8ae2830453a
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA210033
Marketing category
ANDA
Marketing start
2019-07-31
Substance
LORATADINE
Active strength
5 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
good sense childrens allergy relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui665078

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-1019-00good sense childrens allergy relief1 in 1 BLISTER PACKTABLET, CHEWABLE14
0113-1019-00good sense childrens allergy relief20 in 1 CARTONTABLET, CHEWABLE204
0113-1019-39good sense childrens allergy relief30 in 1 CARTONTABLET, CHEWABLE304
0113-1019-39good sense childrens allergy relief1 in 1 BLISTER PACKTABLET, CHEWABLE14
0113-1019-49good sense childrens allergy relief1 in 1 BLISTER PACKTABLET, CHEWABLE14
0113-1019-49good sense childrens allergy relief40 in 1 CARTONTABLET, CHEWABLE404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-1019-39EA - Each0113-10196aff40fd-cf4a-4eab-be04-8e222802a90b12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1019GOOD SENSE CHILDRENS ALLERGY RELIEF (LORATADINE) TABLET, CHEWABLE [L. PERRIGO COMPANY]2Current NDC, Legacy NDC, 6 package rows20200627_643dfe16-9cd1-47bb-8bce-303e6885c644.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN643dfe16-9cd1-47bb-8bce-303e6885c6444
665078loratadine 5 MG Chewable TabletSCD643dfe16-9cd1-47bb-8bce-303e6885c6444

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-1019-000011310190020 BLISTER PACK in 1 CARTON (0113-1019-00) / 1 TABLET, CHEWABLE in 1 BLISTER PACK20 blister pack2026-02-12NoNoHistorical
0113-1019-390011310193930 BLISTER PACK in 1 CARTON (0113-1019-39) > 1 TABLET, CHEWABLE in 1 BLISTER PACK30 blister pack2019-07-310000-00-00NoNoCurrent
0113-1019-490011310194940 BLISTER PACK in 1 CARTON (0113-1019-49) / 1 TABLET, CHEWABLE in 1 BLISTER PACK40 blister pack2025-08-14NoNoHistorical