🇺🇸
United States · US · US:36800-706_790d8277-d9af-46bb-ae3a-dfbf49b3d1be
topcare allergy and congestion relief
Orange BookUNIISPLATC R06AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeR06AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11368007062215 BLISTER PACK in 1 CARTON (36800-706-22) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A075989
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": "36800-706_790d8277-d9af-46bb-ae3a-dfbf49b3d1be",
"productndc": "36800-706",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075989",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG;240MG",
"product_no": "001",
"approval_date": "Mar 4, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
"proprietary_name": "topcare allergy and congestion relief",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA075989",
"marketing_category": "ANDA",
"nonproprietary_name": "loratadine, pseudoephedrine sulfate",
"start_marketing_date": "20230816",
"active_numerator_strength": "10; 240"
}Related drugs
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