🇺🇸
United States · US · US:76162-801_784ad93e-f3b9-48a8-beff-e2aae8b5e147
topcare mucus d
Orange BookUNIISPLATC R05CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeR05CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11761628018918 BLISTER PACK in 1 CARTON (76162-801-89) / 1 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A214407
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "495W7451VQ",
"rxcui": "5032",
"inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
"display_name": "GUAIFENESIN",
"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": "76162-801_784ad93e-f3b9-48a8-beff-e2aae8b5e147",
"productndc": "76162-801",
"dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
"orange_book": {
"appl_no": "214407",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG;60MG",
"product_no": "001",
"approval_date": "Feb 1, 2022"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM;120MG",
"product_no": "002",
"approval_date": "Feb 1, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "topcare mucus d",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA214407",
"marketing_category": "ANDA",
"nonproprietary_name": "guaifenesin and pseudoephedrine hydrochloride",
"start_marketing_date": "20230816",
"active_numerator_strength": "600; 60"
}Related drugs
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