🇺🇸
United States · US · US:36800-825_887383d2-df39-4e9f-9b11-4fa83dc578ce
Topcare Miconazole 7
Orange BookUNIISPLATC G01AF04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeG01AF04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1136800825291 TUBE, WITH APPLICATOR in 1 CARTON (36800-825-29) / 45 g in 1 TUBE, WITH APPLICATOR
Annotations
UNII (FDA Substance ID)
VW4H1CYW1K
MICONAZOLE NITRATE
RxCUI 42790
Orange Book
A074760
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "VW4H1CYW1K",
"rxcui": "42790",
"inchikey": "MCCACAIVAXEFAL-UHFFFAOYSA-N",
"display_name": "MICONAZOLE NITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "VAGINAL",
"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": "36800-825_887383d2-df39-4e9f-9b11-4fa83dc578ce",
"productndc": "36800-825",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "074760",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2%",
"product_no": "001",
"approval_date": "May 15, 1997"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "MICONAZOLE NITRATE",
"proprietary_name": "Topcare Miconazole 7",
"active_ingred_unit": "g/100g",
"application_number": "ANDA074760",
"marketing_category": "ANDA",
"nonproprietary_name": "Miconazole nitrate",
"start_marketing_date": "20000229",
"active_numerator_strength": "2"
}Related drugs
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