🇺🇸
United States · US · US:36800-363_d6a8c36e-4c50-4c16-96a0-2b056a050e17
topcare childrens allergy relief
Orange BookUNIISPLATC R06AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeR06AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11368003633930 BLISTER PACK in 1 CARTON (36800-363-39) / 1 TABLET, CHEWABLE in 1 BLISTER PACK
- ndc11368003634940 BLISTER PACK in 1 CARTON (36800-363-49) / 1 TABLET, CHEWABLE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A210033
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7AJO3BO7QN",
"rxcui": "28889",
"inchikey": "JCCNYMKQOSZNPW-UHFFFAOYSA-N",
"display_name": "LORATADINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
"match": "brand_token",
"title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
"spl_version": "10",
"published_date": "2026-06-01"
}
},
"productid": "36800-363_d6a8c36e-4c50-4c16-96a0-2b056a050e17",
"productndc": "36800-363",
"dosage_form": "TABLET, CHEWABLE",
"orange_book": {
"appl_no": "210033",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Jun 12, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "topcare childrens allergy relief",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210033",
"marketing_category": "ANDA",
"nonproprietary_name": "loratadine",
"start_marketing_date": "20190920",
"active_numerator_strength": "5"
}Related drugs
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