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United States · US · US:0280-6045_4526bb5e-f2d9-1c3e-e063-6394a90a62ae

Aleve-D Sinus and Headache

Orange BookUNIISPLATC G02CC

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

Identification

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

Packs · 1

  • ndc11
    0280604510
    1 BLISTER PACK in 1 CARTON (0280-6045-10) / 10 TABLET 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": {
    "599ea6c8-03ad-536e-e053-2991aa0a83a3": {
      "match": "brand_token",
      "title": "ALEVE-D SINUS AND COLD (NAPROXEN SODIUM, PSEUDEOEPHEDRINE HYDROCHLORIDE) TABLET [BAYER HEALTHCARE LLC.]",
      "spl_version": "8",
      "published_date": "2025-12-05"
    }
  },
  "productid": "0280-6045_4526bb5e-f2d9-1c3e-e063-6394a90a62ae",
  "productndc": "0280-6045",
  "dosage_form": "TABLET",
  "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": "Aleve-D Sinus and Headache",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076518",
  "marketing_category": "ANDA",
  "nonproprietary_name": "naproxen sodium, pseudoephedrine hydrochloride",
  "start_marketing_date": "20140101",
  "active_numerator_strength": "220; 120"
}

Related drugs

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