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United States · US · US:76162-804_27375981-d170-482e-9269-7022762d1780

TOPCARE ARTHRITIS PAIN RELIEVER

Orange BookUNIISPLATC M01AB55

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

Identification

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

Packs · 3

  • ndc11
    7616280401
    1 TUBE in 1 CARTON (76162-804-01) / 100 g in 1 TUBE
  • ndc11
    7616280402
    1 TUBE in 1 CARTON (76162-804-02) / 50 g in 1 TUBE
  • ndc11
    7616280403
    1 TUBE in 1 CARTON (76162-804-03) / 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": {
    "a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
      "match": "brand_token",
      "title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
      "spl_version": "10",
      "published_date": "2026-06-01"
    }
  },
  "productid": "76162-804_27375981-d170-482e-9269-7022762d1780",
  "productndc": "76162-804",
  "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": "TOPCARE ARTHRITIS PAIN RELIEVER",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA211253",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DICLOFENAC SODIUM",
  "start_marketing_date": "20250905",
  "active_numerator_strength": "10"
}

Related drugs

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