Childrens Sudafed PE

UNIISPLATC R01AA04

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

Identification

ManufacturerKenvue Brands LLC

CountryUS (United States)

ATC codeR01AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5058078404
1 BOTTLE in 1 CARTON (50580-784-04) / 118 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

04JA59TNSJ

PHENYLEPHRINE HYDROCHLORIDE

RxCUI 8164

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "04JA59TNSJ",
    "rxcui": "8164",
    "inchikey": "OCYSGIYOVXAGKQ-FVGYRXGTSA-N",
    "display_name": "PHENYLEPHRINE HYDROCHLORIDE",
    "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": "50580-784_23506802-1f31-c967-e063-6394a90a2e7f",
  "productndc": "50580-784",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Childrens Sudafed PE",
  "active_ingred_unit": "mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Phenylephrine hydrochloride",
  "start_marketing_date": "20081001",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code R01AA04.

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