Sudafed PE Head Congestion Plus Pain

Orange BookUNIISPLATC C01EB

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

Identification

ManufacturerKenvue Brands LLC

CountryUS (United States)

ATC codeC01EB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5058043601
2 BLISTER PACK in 1 CARTON (50580-436-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

WK2XYI10QM

IBUPROFEN

RxCUI 5640

Orange Book

A203200

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "WK2XYI10QM",
    "rxcui": "5640",
    "inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
    "display_name": "IBUPROFEN",
    "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": "50580-436_2ffbcc44-0ef3-b149-e063-6394a90ae7f5",
  "productndc": "50580-436",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203200",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG;10MG",
        "product_no": "001",
        "approval_date": "Jul 3, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Sudafed PE Head Congestion Plus Pain",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA203200",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen and Phenylephrine Hydrochloride",
  "start_marketing_date": "20190617",
  "active_numerator_strength": "200; 10"
}

Related drugs

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