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United States · US · US:59640-198_45a40aa3-3eb2-4f37-b9f0-990f7836193e

ARTHRITIS PAIN RELIEVER

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerH E B
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5964019801
    1 TUBE in 1 CARTON (59640-198-01) / 100 g in 1 TUBE
  • ndc11
    5964019802
    1 TUBE in 1 CARTON (59640-198-02) / 50 g in 1 TUBE
  • ndc11
    5964019803
    1 TUBE in 1 CARTON (59640-198-03) / 150 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": {
    "441d0aa0-9a65-98e9-e063-6294a90a5eb2": {
      "match": "brand_token",
      "title": "ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [GROCERY OUTLET, INC.]",
      "spl_version": "3",
      "published_date": "2026-05-25"
    }
  },
  "productid": "59640-198_45a40aa3-3eb2-4f37-b9f0-990f7836193e",
  "productndc": "59640-198",
  "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": "ARTHRITIS PAIN RELIEVER",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA211253",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DICLOFENAC SODIUM",
  "start_marketing_date": "20250422",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code M01AB55.

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