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United States · US · US:50580-437_21ad7bba-a836-8d9d-e063-6294a90a371d

Sudafed PE Sinus Congestion

UNIISPLATC R01AA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeR01AA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5058043701
    1 BLISTER PACK in 1 CARTON (50580-437-01) / 18 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5058043702
    2 BLISTER PACK in 1 CARTON (50580-437-02) / 18 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5058043703
    3 CARTON in 1 PACKAGE (50580-437-03) / 2 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK

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": {
    "67428f4b-28be-4682-a9a9-781bf85089ff": {
      "match": "brand_token",
      "title": "SUDAFED PE SINUS PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [SPORTPHARM LLC]",
      "spl_version": "1",
      "published_date": "2026-03-12"
    }
  },
  "productid": "50580-437_21ad7bba-a836-8d9d-e063-6294a90a371d",
  "productndc": "50580-437",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Sudafed PE Sinus Congestion",
  "active_ingred_unit": "mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Phenylephrine Hydrochloride",
  "start_marketing_date": "20190617",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R01AA04.

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