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United States · US · US:35916-0759_50032ae7-88ff-59ad-e063-6394a90a45c2
Guaifenesin,Dextromethorphan Hbr
UNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSoftgel Healthcare Pvt Ltd
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1135916075932 POUCH in 1 BOX (35916-0759-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH
- ndc1135916075942 BAG in 1 BOX (35916-0759-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
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": {
"3e5d978f-cc70-60a5-e063-6394a90a67d3": {
"match": "brand_token",
"title": "GUAIFENESIN,DEXTROMETHORPHAN HBR CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]",
"spl_version": "4",
"published_date": "2026-04-28"
}
},
"productid": "35916-0759_50032ae7-88ff-59ad-e063-6394a90a45c2",
"productndc": "35916-0759",
"dosage_form": "CAPSULE, LIQUID FILLED",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"proprietary_name": "Guaifenesin,Dextromethorphan Hbr",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Guaifenesin,Dextromethorphan Hbr",
"start_marketing_date": "20250911",
"active_numerator_strength": "20; 400"
}Related drugs
Other records sharing ATC code R05DA.
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