Orajel Antiseptic Alcohol-Free Mouth Sore Rinse

UNIISPL

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

Identification

ManufacturerChurch & Dwight Co., Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1023778416
473.2 mL in 1 BOTTLE (10237-784-16)

Annotations

UNII (FDA Substance ID)

BBX060AN9V

HYDROGEN PEROXIDE

RxCUI 5499

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "BBX060AN9V",
    "rxcui": "5499",
    "inchikey": "MHAJPDPJQMAIIY-UHFFFAOYSA-N",
    "display_name": "HYDROGEN PEROXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ce40829e-941f-2548-e053-2995a90a1e0e": {
      "match": "brand_token",
      "title": "ORAJEL COLD SORE TOUCH FREE - SINGLE DOSE (BENZALKONIUM CHLORIDE, BENZOCAINE) LIQUID [CHURCH & DWIGHT CO., INC.]",
      "spl_version": "6",
      "published_date": "2026-05-15"
    }
  },
  "productid": "10237-784_27ea6bc8-f26b-d947-e063-6394a90ae2f5",
  "productndc": "10237-784",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "HYDROGEN PEROXIDE; MENTHOL, UNSPECIFIED FORM",
  "proprietary_name": "Orajel Antiseptic Alcohol-Free Mouth Sore Rinse",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "M022",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Hydrogen peroxide, Menthol",
  "start_marketing_date": "20191101",
  "active_numerator_strength": "15; 1"
}

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