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United States · US · US:85454-0421_36b1704e-640d-bab5-e063-6394a90a4145

Onral Oral Pain Reliever Mouthwash

UNIISPLATC D04AB04

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

Identification

ManufacturerSyka Pharma Inc.
CountryUS (United States)
ATC codeD04AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8545404211
    1 BOTTLE, PLASTIC in 1 CARTON (85454-0421-1) / 230 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
U3RSY48JW5
BENZOCAINE
RxCUI 1399
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "U3RSY48JW5",
    "rxcui": "1399",
    "inchikey": "BLFLLBZGZJTVJG-UHFFFAOYSA-N",
    "display_name": "BENZOCAINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5dd8d933-6f32-4eaf-8eca-9365d7de55a2": {
      "match": "brand_token",
      "title": "ONRAL ORAL PAIN RELIEVER MOUTHWASH (BENZOCAINE) LIQUID [SYKA PHARMA INC.]",
      "spl_version": "1",
      "published_date": "2025-07-02"
    }
  },
  "productid": "85454-0421_36b1704e-640d-bab5-e063-6394a90a4145",
  "productndc": "85454-0421",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "BENZOCAINE",
  "proprietary_name": "Onral Oral Pain Reliever Mouthwash",
  "active_ingred_unit": "mg/mL",
  "application_number": "M022",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "BENZOCAINE",
  "start_marketing_date": "20250701",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code D04AB04.

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