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United States · US · US:36800-081_28b14543-3ba9-4c9c-a9bd-a94d1ca3bc90
topcare miconazole 3
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1136800081001 KIT in 1 CARTON (36800-081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE
Annotations
Orange Book
A075329
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"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": "36800-081_28b14543-3ba9-4c9c-a9bd-a94d1ca3bc90",
"productndc": "36800-081",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "075329",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2%,200MG",
"product_no": "001",
"approval_date": "Apr 20, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": null,
"proprietary_name": "topcare miconazole 3",
"active_ingred_unit": null,
"application_number": "ANDA075329",
"marketing_category": "ANDA",
"nonproprietary_name": "Miconazole nitrate",
"start_marketing_date": "20000510",
"active_numerator_strength": null
}Access this data programmatically
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