ProRinse Earwax Removal System

UNIISPLATC D02AE01

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

Identification

ManufacturerMcKeon Products Inc

CountryUS (United States)

ATC codeD02AE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6635400782
1 BOTTLE in 1 BOX (66354-007-82) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

31PZ2VAU81

CARBAMIDE PEROXIDE

RxCUI 47686

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "31PZ2VAU81",
    "rxcui": "47686",
    "inchikey": "AQLJVWUFPCUVLO-UHFFFAOYSA-N",
    "display_name": "CARBAMIDE PEROXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "AURICULAR (OTIC)",
  "spl_meta": {
    "ca82db28-1ef7-41c6-a46b-7bfc7b09281c": {
      "match": "brand_token",
      "title": "PRORINSE EARWAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [MCKEON PRODUCTS INC]",
      "spl_version": "1",
      "published_date": "2026-02-10"
    }
  },
  "productid": "66354-007_4a636cb5-104c-7811-e063-6294a90afcb0",
  "productndc": "66354-007",
  "dosage_form": "SOLUTION/ DROPS",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CARBAMIDE PEROXIDE",
  "proprietary_name": "ProRinse Earwax Removal System",
  "active_ingred_unit": "mg/mL",
  "application_number": "M014",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "CARBAMIDE PEROXIDE",
  "start_marketing_date": "20260205",
  "active_numerator_strength": "65"
}

Related drugs

Other records sharing ATC code D02AE01.

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