FDA.reportPublic FDA data

DYE-FREE CHILDRENS LORATADINE

Product NDC
51660-726
11-digit product format
516600726
Labeler code
51660
Product ID
51660-726_10b0df2b-89b6-c4f8-e063-6294a90a68ed
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA210088
Marketing category
ANDA
Marketing start
2024-03-15
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
DYE-FREE CHILDRENS LORATADINE
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-726-30DYE-FREE CHILDRENS LORATADINE10 in 1 BLISTER PACKTABLET, CHEWABLE101
51660-726-30DYE-FREE CHILDRENS LORATADINE3 in 1 CARTONTABLET, CHEWABLE31
51660-726-61DYE-FREE CHILDRENS LORATADINE10 in 1 BLISTER PACKTABLET, CHEWABLE101
51660-726-61DYE-FREE CHILDRENS LORATADINE6 in 1 CARTONTABLET, CHEWABLE61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-726DYE-FREE CHILDRENS LORATADINE (LORATADINE) TABLET, CHEWABLE [OHM LABORATORIES INC.]1Current NDC, 4 package rows20250110_10b0e325-335b-05b6-e063-6394a90a8c2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN10b0e325-335b-05b6-e063-6394a90a8c2f1
665078loratadine 5 MG Chewable TabletSCD10b0e325-335b-05b6-e063-6394a90a8c2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51660-726-30516600726303 BLISTER PACK in 1 CARTON (51660-726-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2024-03-15NoNoCurrent
51660-726-61516600726616 BLISTER PACK in 1 CARTON (51660-726-61) / 10 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2024-10-18NoNoCurrent