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United States · US · US:50580-434_21abbf03-2010-4650-e063-6294a90a6edb

Sudafed Sinus 12 Hour Pressure plus Pain

Orange BookUNIISPLATC G02CC

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

Identification

ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeG02CC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5058043401
    2 BLISTER PACK in 1 CARTON (50580-434-01) / 8 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A076518
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9TN87S3A3C",
    "rxcui": "142442",
    "inchikey": "CDBRNDSHEYLDJV-FVGYRXGTSA-M",
    "display_name": "NAPROXEN SODIUM",
    "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": "50580-434_21abbf03-2010-4650-e063-6294a90a6edb",
  "productndc": "50580-434",
  "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "076518",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "220MG;120MG",
        "product_no": "001",
        "approval_date": "Mar 17, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "Sudafed Sinus 12 Hour Pressure plus Pain",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076518",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen sodium and Pseudoephedrine Hydrochloride",
  "start_marketing_date": "20190617",
  "active_numerator_strength": "220; 120"
}

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