🇺🇸
United States · US · US:36800-612_9fd9c4c8-9520-470a-9deb-e050233a6e92
TopCare 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 · 5
- ndc1136800612031 BOTTLE in 1 CARTON (36800-612-03) / 70 TABLET in 1 BOTTLE
- ndc11368006124610 BLISTER PACK in 1 CARTON (36800-612-46) / 1 TABLET in 1 BLISTER PACK
- ndc1136800612581 BOTTLE in 1 CARTON (36800-612-58) / 40 TABLET in 1 BOTTLE
- ndc1136800612651 BOTTLE in 1 CARTON (36800-612-65) / 30 TABLET in 1 BOTTLE
- ndc1136800612871 BOTTLE in 1 CARTON (36800-612-87) / 300 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076301
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": "36800-612_9fd9c4c8-9520-470a-9deb-e050233a6e92",
"productndc": "36800-612",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076301",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Jun 25, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE",
"proprietary_name": "TopCare Allergy Relief",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076301",
"marketing_category": "ANDA",
"nonproprietary_name": "Loratadine",
"start_marketing_date": "20050125",
"active_numerator_strength": "10"
}Related drugs
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