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United States · US · US:50090-6078_049a1f87-10ee-4c8a-858b-218611764bff
MUCINEX
Orange BookUNIISPLATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115009060780480 TABLET, EXTENDED RELEASE in 1 CASE (50090-6078-0)
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
N021282
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": {
"49f1f415-8017-0974-e063-6294a90a8918": {
"match": "brand_token",
"title": "MUCINEX 12HR COLD AND FEVER MULTI-SYMPTOM (NAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [RB HEALTH (US) LLC]",
"spl_version": "1",
"published_date": "2026-06-02"
}
},
"productid": "50090-6078_049a1f87-10ee-4c8a-858b-218611764bff",
"productndc": "50090-6078",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "021282",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "Jul 12, 2002"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1.2GM",
"product_no": "002",
"approval_date": "Dec 18, 2002"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN",
"proprietary_name": "MUCINEX",
"active_ingred_unit": "mg/1",
"application_number": "NDA021282",
"marketing_category": "NDA",
"nonproprietary_name": "Guaifenesin",
"start_marketing_date": "20120703",
"active_numerator_strength": "600"
}Related drugs
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