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United States · US · US:0067-8152_71ee74f6-1c1d-4ba8-95be-9b9aefc02d3c

Voltaren

Orange BookUNIISPLATC M01AB55

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

Identification

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

Packs · 6

  • ndc11
    0067815201
    1 TUBE in 1 CARTON (0067-8152-01) / 20 g in 1 TUBE
  • ndc11
    0067815202
    1 TUBE in 1 CARTON (0067-8152-02) / 50 g in 1 TUBE
  • ndc11
    0067815203
    1 TUBE in 1 CARTON (0067-8152-03) / 100 g in 1 TUBE
  • ndc11
    0067815204
    1 TUBE in 1 CARTON (0067-8152-04) / 150 g in 1 TUBE
  • ndc11
    0067815208
    2 TUBE in 1 CARTON (0067-8152-08) / 100 g in 1 TUBE
  • ndc11
    0067815209
    1 TUBE in 1 CARTON (0067-8152-09) / 20 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
N022122
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": {
    "30a94282-0892-442a-aa10-6525cbd4fe88": {
      "match": "brand_token",
      "title": "VOLTAREN ARTHRITIS PAIN (DICLOFENAC SODIUM) GEL VOLTAREN ARTHRITIS PAIN (DICLOFENAC SODIUM) KIT [HALEON US HOLDINGS LLC]",
      "spl_version": "13",
      "published_date": "2025-02-21"
    }
  },
  "productid": "0067-8152_71ee74f6-1c1d-4ba8-95be-9b9aefc02d3c",
  "productndc": "0067-8152",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "022122",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Oct 17, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DICLOFENAC SODIUM",
  "proprietary_name": "Voltaren",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA022122",
  "marketing_category": "NDA",
  "nonproprietary_name": "diclofenac sodium",
  "start_marketing_date": "20200513",
  "active_numerator_strength": "10"
}

Related drugs

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