childrens allergy

Generic: loratadine

Labeler: wal-mart stores inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens allergy
Generic Name loratadine
Labeler wal-mart stores inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loratadine 5 mg/5mL

Manufacturer
Wal-Mart Stores Inc

Identifiers & Regulatory

Product NDC 49035-538
Product ID 49035-538_6ee5b7e9-711d-4d18-9cea-09a4d19d4332
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA201865
Listing Expiration 2026-12-31
Marketing Start 2016-12-08

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49035538
Hyphenated Format 49035-538

Supplemental Identifiers

RxCUI
692783
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 childrens allergy (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA201865 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (49035-538-08) / 120 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (49035-538-09) / 120 mL in 1 BOTTLE
source: ndc

Packages (2)

49035-538-08 1 BOTTLE in 1 CARTON (49035-538-08) / 120 mL in 1 BOTTLE 49035-538-09 1 BOTTLE in 1 CARTON (49035-538-09) / 120 mL in 1 BOTTLE

Ingredients (1)

loratadine (5 mg/5mL)

Linked Drug Pages (1)

Childrens Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6ee5b7e9-711d-4d18-9cea-09a4d19d4332", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["692783"], "spl_set_id": ["9fb3a3a8-8812-4238-b596-291b79085db9"], "manufacturer_name": ["Wal-Mart Stores Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (49035-538-08)  / 120 mL in 1 BOTTLE", "package_ndc": "49035-538-08", "marketing_start_date": "20190621"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (49035-538-09)  / 120 mL in 1 BOTTLE", "package_ndc": "49035-538-09", "marketing_start_date": "20210307"}], "brand_name": "Childrens Allergy", "product_id": "49035-538_6ee5b7e9-711d-4d18-9cea-09a4d19d4332", "dosage_form": "SOLUTION", "product_ndc": "49035-538", "generic_name": "Loratadine", "labeler_name": "Wal-Mart Stores Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Allergy", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/5mL"}], "application_number": "ANDA201865", "marketing_category": "ANDA", "marketing_start_date": "20161208", "listing_expiration_date": "20261231"}