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United States · US · US:17856-0008_45244b74-1b9b-2f5d-e063-6394a90a1002
Mucinex
Orange BookUNIISPLATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerATLANTIC BIOLOGICAS CORP.
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1117856000821 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (17856-0008-2)
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": "17856-0008_45244b74-1b9b-2f5d-e063-6394a90a1002",
"productndc": "17856-0008",
"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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