cliniclean

Generic: chlorhexidine gluconate 4%

Labeler: xttrium laboratories, inc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cliniclean
Generic Name chlorhexidine gluconate 4%
Labeler xttrium laboratories, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

chlorhexidine gluconate 4 g/100mL

Manufacturer
Xttrium Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0116-0901
Product ID 0116-0901_4573a83b-5e15-dabf-e063-6394a90a44ee
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019125
Listing Expiration 2026-12-31
Marketing Start 2023-03-23

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01160901
Hyphenated Format 0116-0901

Supplemental Identifiers

RxCUI
211365
UPC
0694640161162 0694640161087
UNII
MOR84MUD8E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cliniclean (source: ndc)
Generic Name chlorhexidine gluconate 4% (source: ndc)
Application Number NDA019125 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 4 g/100mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (0116-0901-16)
  • 946 mL in 1 BOTTLE (0116-0901-32)
source: ndc

Packages (2)

0116-0901-16 473 mL in 1 BOTTLE (0116-0901-16) 0116-0901-32 946 mL in 1 BOTTLE (0116-0901-32)

Ingredients (1)

chlorhexidine gluconate (4 g/100mL)

Linked Drug Pages (2)

CliniClean ndc-match (0.9) CliniClean ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4573a83b-5e15-dabf-e063-6394a90a44ee", "openfda": {"upc": ["0694640161162", "0694640161087"], "unii": ["MOR84MUD8E"], "rxcui": ["211365"], "spl_set_id": ["f8352f15-b481-ee95-e053-6294a90ac535"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0116-0901-16)", "package_ndc": "0116-0901-16", "marketing_start_date": "20230323"}, {"sample": false, "description": "946 mL in 1 BOTTLE (0116-0901-32)", "package_ndc": "0116-0901-32", "marketing_start_date": "20230323"}], "brand_name": "CliniClean", "product_id": "0116-0901_4573a83b-5e15-dabf-e063-6394a90a44ee", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "0116-0901", "generic_name": "CHLORHEXIDINE GLUCONATE 4%", "labeler_name": "Xttrium Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CliniClean", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "4 g/100mL"}], "application_number": "NDA019125", "marketing_category": "NDA", "marketing_start_date": "20230323", "listing_expiration_date": "20261231"}