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United States · US · US:0234-0575_29f35571-d7a5-b30f-e063-6394a90aca88

Hibiclens

Orange BookUNIISPLATC D08AC02

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

Identification

ManufacturerMolnlycke Health Care
CountryUS (United States)
ATC codeD08AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0234057540
    118 mL in 1 BOTTLE (0234-0575-40)
  • ndc11
    0234057541
    118 mL in 1 BOTTLE, PUMP (0234-0575-41)
  • ndc11
    0234057580
    236 mL in 1 BOTTLE, PUMP (0234-0575-80)

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": "0234-0575_29f35571-d7a5-b30f-e063-6394a90aca88",
  "productndc": "0234-0575",
  "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": "20160215",
  "active_numerator_strength": "4"
}

Related drugs

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