topcare childrens allergy relief

Generic: loratadine

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare childrens allergy relief
Generic Name loratadine
Labeler topco associates llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

loratadine 5 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-363
Product ID 36800-363_d6a8c36e-4c50-4c16-96a0-2b056a050e17
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210033
Listing Expiration 2026-12-31
Marketing Start 2019-09-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800363
Hyphenated Format 36800-363

Supplemental Identifiers

RxCUI
665078
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 topcare childrens allergy relief (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA210033 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (36800-363-39) / 1 TABLET, CHEWABLE in 1 BLISTER PACK
  • 40 BLISTER PACK in 1 CARTON (36800-363-49) / 1 TABLET, CHEWABLE in 1 BLISTER PACK
source: ndc

Packages (2)

36800-363-39 30 BLISTER PACK in 1 CARTON (36800-363-39) / 1 TABLET, CHEWABLE in 1 BLISTER PACK 36800-363-49 40 BLISTER PACK in 1 CARTON (36800-363-49) / 1 TABLET, CHEWABLE in 1 BLISTER PACK

Ingredients (1)

loratadine (5 mg/1)

Linked Drug Pages (1)

topcare childrens allergy relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d6a8c36e-4c50-4c16-96a0-2b056a050e17", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["665078"], "spl_set_id": ["4f7555ea-6286-4ff6-b125-d12660ae4bdf"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (36800-363-39)  / 1 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "36800-363-39", "marketing_start_date": "20190920"}, {"sample": false, "description": "40 BLISTER PACK in 1 CARTON (36800-363-49)  / 1 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "36800-363-49", "marketing_start_date": "20230620"}], "brand_name": "topcare childrens allergy relief", "product_id": "36800-363_d6a8c36e-4c50-4c16-96a0-2b056a050e17", "dosage_form": "TABLET, CHEWABLE", "product_ndc": "36800-363", "generic_name": "loratadine", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare childrens allergy relief", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/1"}], "application_number": "ANDA210033", "marketing_category": "ANDA", "marketing_start_date": "20190920", "listing_expiration_date": "20261231"}