Childrens SUDAFED PE Cold plus Cough

UNIISPLATC R05DA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerKenvue Brands LLC

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5058078504
1 BOTTLE in 1 CARTON (50580-785-04) / 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": {
    "436c0126-4ff3-c082-e063-6294a90a3d72": {
      "match": "brand_token",
      "title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50580-785_23508e92-0823-8827-e063-6394a90aeb9d",
  "productndc": "50580-785",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Childrens SUDAFED PE Cold plus Cough",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Dextromethorphan hydrobromide and Phenylephrine hydrochloride",
  "start_marketing_date": "20081001",
  "active_numerator_strength": "5; 2.5"
}

Related drugs

Other records sharing ATC code R05DA.

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