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_461400df-dad0-2b8f-e063-6394a90a44f8
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
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
  • 50 PACKET in 1 CARTON (0116-0901-15) / 15 mL in 1 PACKET
source: ndc

Packages (1)

0116-0901-15 50 PACKET in 1 CARTON (0116-0901-15) / 15 mL in 1 PACKET

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": "461400df-dad0-2b8f-e063-6394a90a44f8", "openfda": {"unii": ["MOR84MUD8E"], "rxcui": ["211365"], "spl_set_id": ["f8354044-6b99-6d2c-e053-6294a90a74b2"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (0116-0901-15)  / 15 mL in 1 PACKET", "package_ndc": "0116-0901-15", "marketing_start_date": "20230323"}], "brand_name": "CliniClean", "product_id": "0116-0901_461400df-dad0-2b8f-e063-6394a90a44f8", "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"}