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United States · US · US:50580-363_21707bfd-d78e-0f04-e063-6294a90a8945

SUDAFED Sinus Congestion

UNIISPLATC R01BA52

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

Identification

ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeR01BA52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5058036301
    4 BLISTER PACK in 1 CARTON (50580-363-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5058036302
    2 BLISTER PACK in 1 CARTON (50580-363-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5058036303
    3 CARTON in 1 PACKAGE (50580-363-03) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6V9V2RYJ8N",
    "rxcui": "91168",
    "inchikey": "BALXUFOVQVENIU-KXNXZCPBSA-N",
    "display_name": "PSEUDOEPHEDRINE 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": "50580-363_21707bfd-d78e-0f04-e063-6294a90a8945",
  "productndc": "50580-363",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "SUDAFED Sinus Congestion",
  "active_ingred_unit": "mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Pseudoephedrine Hydrochloride",
  "start_marketing_date": "20210731",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code R01BA52.

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