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United States · US · US:11084-128_8bc40612-5f9c-4de9-b3e7-42fe12678853

Bactoshield CHG

Orange BookUNIISPLATC D08AC02

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

Identification

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

Packs · 2

  • ndc11
    1108412803
    118 mL in 1 BOTTLE (11084-128-03)
  • ndc11
    1108412824
    946 mL in 1 BOTTLE (11084-128-24)

Annotations

UNII (FDA Substance ID)
MOR84MUD8E
CHLORHEXIDINE GLUCONATE
RxCUI 20791
Orange Book
N019258
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": {
    "4a6403ad-fa5e-2b4a-e054-00144ff8d46c": {
      "match": "brand_token",
      "title": "BACTOSHIELD CHG (CHLORHEXIDINE GLUCONATE) SOLUTION [XTTRIUM LABORATORIES, INC.]",
      "spl_version": "7",
      "published_date": "2026-04-30"
    }
  },
  "productid": "11084-128_8bc40612-5f9c-4de9-b3e7-42fe12678853",
  "productndc": "11084-128",
  "dosage_form": "LIQUID",
  "orange_book": {
    "appl_no": "019258",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Jul 22, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4%",
        "product_no": "002",
        "approval_date": "Jul 22, 1986"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CHLORHEXIDINE GLUCONATE",
  "proprietary_name": "Bactoshield CHG",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019258",
  "marketing_category": "NDA",
  "nonproprietary_name": "CHLORHEXIDINE GLUCONATE",
  "start_marketing_date": "20190815",
  "active_numerator_strength": "40"
}

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