🇺🇸
United States · US · US:70000-0720_a9b992f9-5780-4bb2-abfa-8f8717de8ddc
Leader Mucus Relief D
Orange BookUNIISPLATC R05CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeR05CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170000072011 BLISTER PACK in 1 CARTON (70000-0720-1) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1170000072022 BLISTER PACK in 1 CARTON (70000-0720-2) / 18 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": {
"12971fb2-2314-4443-bf70-b7eb5859b148": {
"match": "brand_token",
"title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
"spl_version": "3",
"published_date": "2026-06-01"
}
},
"productid": "70000-0720_a9b992f9-5780-4bb2-abfa-8f8717de8ddc",
"productndc": "70000-0720",
"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": "Leader Mucus Relief D",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA214407",
"marketing_category": "ANDA",
"nonproprietary_name": "guaifenesin and pseudoephedrine hydrochloride",
"start_marketing_date": "20250310",
"active_numerator_strength": "600; 60"
}Related drugs
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