provon antimicrobial foam handwash

Generic: chlorhexidine gluconate 2%

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

Drug Facts

Product Profile

Brand Name provon antimicrobial foam handwash
Generic Name chlorhexidine gluconate 2%
Labeler xttrium laboratories, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

chlorhexidine gluconate 20 mg/mL

Manufacturer
Xttrium Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0116-8500
Product ID 0116-8500_340029e6-b385-3a47-e063-6394a90acbc9
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019422
Listing Expiration 2026-12-31
Marketing Start 2016-07-01

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01168500
Hyphenated Format 0116-8500

Supplemental Identifiers

RxCUI
1245230
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 provon antimicrobial foam handwash (source: ndc)
Generic Name chlorhexidine gluconate 2% (source: ndc)
Application Number NDA019422 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1200 mL in 1 BOTTLE, DISPENSING (0116-8500-89)
  • 1250 mL in 1 BOTTLE, DISPENSING (0116-8500-90)
source: ndc

Packages (2)

0116-8500-89 1200 mL in 1 BOTTLE, DISPENSING (0116-8500-89) 0116-8500-90 1250 mL in 1 BOTTLE, DISPENSING (0116-8500-90)

Ingredients (1)

chlorhexidine gluconate (20 mg/mL)

Linked Drug Pages (1)

Provon Antimicrobial Foam Handwash ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "340029e6-b385-3a47-e063-6394a90acbc9", "openfda": {"unii": ["MOR84MUD8E"], "rxcui": ["1245230"], "spl_set_id": ["46dd136c-d569-0450-e054-00144ff8d46c"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1200 mL in 1 BOTTLE, DISPENSING (0116-8500-89)", "package_ndc": "0116-8500-89", "marketing_start_date": "20160701"}, {"sample": false, "description": "1250 mL in 1 BOTTLE, DISPENSING (0116-8500-90)", "package_ndc": "0116-8500-90", "marketing_start_date": "20160701"}], "brand_name": "Provon Antimicrobial Foam Handwash", "product_id": "0116-8500_340029e6-b385-3a47-e063-6394a90acbc9", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "0116-8500", "generic_name": "Chlorhexidine Gluconate 2%", "labeler_name": "Xttrium Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Provon Antimicrobial Foam Handwash", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "20 mg/mL"}], "application_number": "NDA019422", "marketing_category": "NDA", "marketing_start_date": "20160701", "listing_expiration_date": "20261231"}