Back to search
🇺🇸

United States · US · US:76420-535_23b4100e-49d1-0cb6-e063-6394a90a9d24

Hibiclens

Orange BookUNIISPLATC D08AC02

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

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeD08AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7642053508
    236 mL in 1 BOTTLE (76420-535-08)

Annotations

UNII (FDA Substance ID)
MOR84MUD8E
CHLORHEXIDINE GLUCONATE
RxCUI 20791
Orange Book
N017768
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MOR84MUD8E",
    "rxcui": "20791",
    "inchikey": "YZIYKJHYYHPJIB-UUPCJSQJSA-N",
    "display_name": "CHLORHEXIDINE GLUCONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "4275eb53-1a7e-4a91-aac1-1085f40fac88": {
      "match": "brand_token",
      "title": "HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE]",
      "spl_version": "13",
      "published_date": "2024-12-25"
    }
  },
  "productid": "76420-535_23b4100e-49d1-0cb6-e063-6394a90a9d24",
  "productndc": "76420-535",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "017768",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CHLORHEXIDINE GLUCONATE",
  "proprietary_name": "Hibiclens",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA017768",
  "marketing_category": "NDA",
  "nonproprietary_name": "Chlorhexidine Gluconate",
  "start_marketing_date": "19760917",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code D08AC02.

Access this data programmatically

Query Hibiclens and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.