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United States · US · US:36800-811_42eac10e-3ec4-4eaf-9e97-c50e2568430e
topcare childrens ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1136800811621 BOTTLE in 1 CARTON (36800-811-62) / 24 TABLET, CHEWABLE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A076359
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WK2XYI10QM",
"rxcui": "5640",
"inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
"display_name": "IBUPROFEN",
"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": "36800-811_42eac10e-3ec4-4eaf-9e97-c50e2568430e",
"productndc": "36800-811",
"dosage_form": "TABLET, CHEWABLE",
"orange_book": {
"appl_no": "076359",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "Jan 16, 2004"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "100MG",
"product_no": "002",
"approval_date": "Jan 16, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "topcare childrens ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076359",
"marketing_category": "ANDA",
"nonproprietary_name": "ibuprofen",
"start_marketing_date": "20190904",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G02CC01.
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