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United States · US · US:58552-131_40b823a5-5359-e635-e063-6394a90a4283
Giltuss Childrens Cough and Cold
UNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGil Pharmaceutical Corp
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1158552131041 BOTTLE in 1 CARTON (58552-131-04) / 118 mL in 1 BOTTLE
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": "58552-131_40b823a5-5359-e635-e063-6394a90a4283",
"productndc": "58552-131",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"proprietary_name": "Giltuss Childrens Cough and Cold",
"active_ingred_unit": "mg/2.5mL; mg/2.5mL; mg/2.5mL",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride",
"start_marketing_date": "20181107",
"active_numerator_strength": "7.5; 150; 5"
}Related drugs
Other records sharing ATC code R05DA.
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