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United States · US · US:50580-787_291005be-b77a-be4a-e063-6294a90a04f0

SUDAFED OM Sinus Severe Original

UNIISPLATC D11AX27

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

Identification

ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeD11AX27
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5058078701
    1 BOTTLE in 1 CARTON (50580-787-01) / 30 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
K89MJ0S5VY
OXYMETAZOLINE HYDROCHLORIDE
RxCUI 106101
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "K89MJ0S5VY",
    "rxcui": "106101",
    "inchikey": "BEEDODBODQVSIM-UHFFFAOYSA-N",
    "display_name": "OXYMETAZOLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "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": "50580-787_291005be-b77a-be4a-e063-6294a90a04f0",
  "productndc": "50580-787",
  "dosage_form": "SPRAY",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OXYMETAZOLINE HYDROCHLORIDE",
  "proprietary_name": "SUDAFED OM Sinus Severe Original",
  "active_ingred_unit": "mg/100mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Oxymetazoline Hydrochloride",
  "start_marketing_date": "20240904",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code D11AX27.

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