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United States · US · US:0280-0039_452615d3-7d62-4fa6-e063-6394a90a5dfd

Aleve Arthritis Pain Gel

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerBayer HealthCare LLC
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0280003901
    1 TUBE in 1 CARTON (0280-0039-01) / 100 g in 1 TUBE
  • ndc11
    0280003902
    1 TUBE in 1 CARTON (0280-0039-02) / 50 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A211253
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "QTG126297Q",
    "rxcui": "203214",
    "inchikey": "KPHWPUGNDIVLNH-UHFFFAOYSA-M",
    "display_name": "DICLOFENAC SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "590f3be2-20df-4643-9114-e7ed4cf9155c": {
      "match": "brand_token",
      "title": "ALEVE (NAPROXEN SODIUM) TABLET [NAVAJO MANUFACTURING COMPANY INC.]",
      "spl_version": "5",
      "published_date": "2026-04-09"
    }
  },
  "productid": "0280-0039_452615d3-7d62-4fa6-e063-6394a90a5dfd",
  "productndc": "0280-0039",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "211253",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "May 16, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DICLOFENAC SODIUM",
  "proprietary_name": "Aleve Arthritis Pain Gel",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA211253",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code M01AB55.

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