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United States · US · US:0037-6822_d63033a1-dca0-44f9-a6f3-210e38c2691e

PROCTOFOAM

Orange BookUNIISPLATC D07AB

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

Identification

ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeD07AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0037682210
    1 CANISTER in 1 CARTON (0037-6822-10) / 10 g in 1 CANISTER

Annotations

UNII (FDA Substance ID)
3X7931PO74
HYDROCORTISONE ACETATE
RxCUI 27197
Orange Book
A086195
BX
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3X7931PO74",
    "rxcui": "27197",
    "inchikey": "ALEXXDVDDISNDU-JZYPGELDSA-N",
    "display_name": "HYDROCORTISONE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "cddc8d81-21b8-11e4-8c21-0800200c9a66": {
      "match": "brand_token",
      "title": "PROCTOFOAM NS (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [VIATRIS SPECIALTY LLC]",
      "spl_version": "6",
      "published_date": "2025-08-28"
    }
  },
  "productid": "0037-6822_d63033a1-dca0-44f9-a6f3-210e38c2691e",
  "productndc": "0037-6822",
  "dosage_form": "AEROSOL, FOAM",
  "orange_book": {
    "appl_no": "086195",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "BX",
        "strength": "1%;1%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
  "proprietary_name": "PROCTOFOAM",
  "active_ingred_unit": "mg/10g; mg/10g",
  "application_number": "ANDA086195",
  "marketing_category": "ANDA",
  "nonproprietary_name": "pramoxine hydrochloride hydrocortisone acetate",
  "start_marketing_date": "20140815",
  "active_numerator_strength": "100; 100"
}

Related drugs

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