children claritin allergy

Generic: loratadine

Labeler: bayer healthcare llc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name children claritin allergy
Generic Name loratadine
Labeler bayer healthcare llc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loratadine 5 mg/5mL

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 11523-4360
Product ID 11523-4360_352ebcfd-07bb-a60e-e063-6394a90a5d70
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020641
Listing Expiration 2026-12-31
Marketing Start 2015-05-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 115234360
Hyphenated Format 11523-4360

Supplemental Identifiers

RxCUI
692783 755476
UPC
0041100810991
UNII
7AJO3BO7QN

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name children claritin allergy (source: ndc)
Generic Name loratadine (source: ndc)
Application Number NDA020641 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (11523-4360-1) / 60 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (11523-4360-2) / 120 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (11523-4360-3) / 150 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (11523-4360-4) / 30 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (11523-4360-5) / 240 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (11523-4360-6) / 180 mL in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (11523-4360-7) / 180 mL in 1 BOTTLE
source: ndc

Packages (7)

11523-4360-1 1 BOTTLE in 1 CARTON (11523-4360-1) / 60 mL in 1 BOTTLE 11523-4360-2 1 BOTTLE in 1 CARTON (11523-4360-2) / 120 mL in 1 BOTTLE 11523-4360-3 1 BOTTLE in 1 CARTON (11523-4360-3) / 150 mL in 1 BOTTLE 11523-4360-4 1 BOTTLE in 1 CARTON (11523-4360-4) / 30 mL in 1 BOTTLE 11523-4360-5 1 BOTTLE in 1 CARTON (11523-4360-5) / 240 mL in 1 BOTTLE 11523-4360-6 1 BOTTLE in 1 CARTON (11523-4360-6) / 180 mL in 1 BOTTLE 11523-4360-7 2 BOTTLE in 1 CARTON (11523-4360-7) / 180 mL in 1 BOTTLE

Ingredients (1)

loratadine (5 mg/5mL)

Linked Drug Pages (1)

Children Claritin Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "352ebcfd-07bb-a60e-e063-6394a90a5d70", "openfda": {"upc": ["0041100810991"], "unii": ["7AJO3BO7QN"], "rxcui": ["692783", "755476"], "spl_set_id": ["170061e9-e529-4ff0-e054-00144ff8d46c"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (11523-4360-1)  / 60 mL in 1 BOTTLE", "package_ndc": "11523-4360-1", "marketing_start_date": "20150526"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (11523-4360-2)  / 120 mL in 1 BOTTLE", "package_ndc": "11523-4360-2", "marketing_start_date": "20150925"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (11523-4360-3)  / 150 mL in 1 BOTTLE", "package_ndc": "11523-4360-3", "marketing_start_date": "20160101"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (11523-4360-4)  / 30 mL in 1 BOTTLE", "package_ndc": "11523-4360-4", "marketing_start_date": "20151101"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (11523-4360-5)  / 240 mL in 1 BOTTLE", "package_ndc": "11523-4360-5", "marketing_start_date": "20150526"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (11523-4360-6)  / 180 mL in 1 BOTTLE", "package_ndc": "11523-4360-6", "marketing_start_date": "20151005"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (11523-4360-7)  / 180 mL in 1 BOTTLE", "package_ndc": "11523-4360-7", "marketing_start_date": "20160301"}], "brand_name": "Children Claritin Allergy", "product_id": "11523-4360_352ebcfd-07bb-a60e-e063-6394a90a5d70", "dosage_form": "SOLUTION", "product_ndc": "11523-4360", "generic_name": "loratadine", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Children Claritin", "brand_name_suffix": "Allergy", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/5mL"}], "application_number": "NDA020641", "marketing_category": "NDA", "marketing_start_date": "20150526", "listing_expiration_date": "20261231"}