🇺🇸
United States · US · US:70000-0195_780efed5-fb7e-4bde-baa4-37807cd96914
leader childrens cough dm
Orange BookUNIISPLATC N07XX59
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeN07XX59
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170000019511 BOTTLE in 1 CARTON (70000-0195-1) / 89 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A091135
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9D2RTI9KYH",
"rxcui": "102490",
"inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
"display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
"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": "70000-0195_780efed5-fb7e-4bde-baa4-37807cd96914",
"productndc": "70000-0195",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "091135",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 30MG HYDROBROMIDE/5ML",
"product_no": "001",
"approval_date": "May 25, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE",
"proprietary_name": "leader childrens cough dm",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA091135",
"marketing_category": "ANDA",
"nonproprietary_name": "dextromethorphan polistirex",
"start_marketing_date": "20161115",
"active_numerator_strength": "30"
}Related drugs
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