MOTRIN ARTHRITIS PAIN

Orange BookUNIISPLATC M01AB55

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerKenvue Brands LLC

CountryUS (United States)

ATC codeM01AB55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5058057401
1 TUBE in 1 CARTON (50580-574-01) / 50 g in 1 TUBE
ndc11
5058057402
1 TUBE in 1 CARTON (50580-574-02) / 100 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": {
    "c57f6ded-c0bd-45ae-823a-4c02ce334d98": {
      "match": "brand_token",
      "title": "MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [KENVUE BRANDS LLC]",
      "spl_version": "17",
      "published_date": "2026-05-20"
    }
  },
  "productid": "50580-574_21aceda5-2c35-23df-e063-6394a90acb09",
  "productndc": "50580-574",
  "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": "MOTRIN ARTHRITIS PAIN",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA211253",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac sodium",
  "start_marketing_date": "20220620",
  "active_numerator_strength": "9.3"
}

Related drugs

Other records sharing ATC code M01AB55.

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