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United States · US · US:65852-019_40802fb6-c1ed-d7b0-e063-6394a90ab423
Giltuss Childrens Cough and Chest Congestion
UNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDextrum Laboratories, Inc
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165852019041 BOTTLE, PLASTIC in 1 CARTON (65852-019-04) / 118 mL in 1 BOTTLE, PLASTIC
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": {
"950db1ca-6936-47f8-a112-e3594d4c922c": {
"match": "brand_token",
"title": "GILTUSS EX MAXIMUM STRENGTH EXPECTORANT TABLET [GIL PHARMACEUTICAL CORP]",
"spl_version": "2",
"published_date": "2026-05-14"
}
},
"productid": "65852-019_40802fb6-c1ed-d7b0-e063-6394a90ab423",
"productndc": "65852-019",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"proprietary_name": "Giltuss Childrens Cough and Chest Congestion",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Dextromethorphan hydrobromide, Guaifenesin",
"start_marketing_date": "20181002",
"active_numerator_strength": "10; 100"
}Related drugs
Other records sharing ATC code R05DA.
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