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United States · US · US:0234-0575_29f3a722-b70e-15f6-e063-6294a90a474f

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 · 5

  • ndc11
    0234057504
    118 mL in 1 BOTTLE (0234-0575-04)
  • ndc11
    0234057508
    236 mL in 1 BOTTLE (0234-0575-08)
  • ndc11
    0234057516
    473 mL in 1 BOTTLE (0234-0575-16)
  • ndc11
    0234057532
    946 mL in 1 BOTTLE (0234-0575-32)
  • ndc11
    0234057591
    3790 mL in 1 BOTTLE (0234-0575-91)

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_29f3a722-b70e-15f6-e063-6294a90a474f",
  "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": "19760917",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code D08AC02.

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