antiseptic skin cleanser

Generic: chlorhexidine gluconate 4%

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

Drug Facts

Product Profile

Brand Name antiseptic skin cleanser
Generic Name chlorhexidine gluconate 4%
Labeler xttrium laboratories, inc.
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

chlorhexidine gluconate 4 g/100mL

Manufacturer
Xttrium Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0116-0767
Product ID 0116-0767_457387bd-dcc2-ade6-e063-6394a90aa6b5
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019125
Listing Expiration 2026-12-31
Marketing Start 2011-08-31

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01160767
Hyphenated Format 0116-0767

Supplemental Identifiers

RxCUI
211365
UPC
0050428412282
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 antiseptic skin cleanser (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
  • 237 mL in 1 BOTTLE (0116-0767-08)
  • 473 mL in 1 BOTTLE (0116-0767-16)
  • 532 mL in 1 BOTTLE, PUMP (0116-0767-18)
source: ndc

Packages (3)

0116-0767-08 237 mL in 1 BOTTLE (0116-0767-08) 0116-0767-16 473 mL in 1 BOTTLE (0116-0767-16) 0116-0767-18 532 mL in 1 BOTTLE, PUMP (0116-0767-18)

Ingredients (1)

chlorhexidine gluconate (4 g/100mL)

Linked Drug Pages (1)

Antiseptic Skin Cleanser ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "457387bd-dcc2-ade6-e063-6394a90aa6b5", "openfda": {"upc": ["0050428412282"], "unii": ["MOR84MUD8E"], "rxcui": ["211365"], "spl_set_id": ["48a814e7-bfe4-5437-e054-00144ff88e88"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (0116-0767-08)", "package_ndc": "0116-0767-08", "marketing_start_date": "20110831"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0116-0767-16)", "package_ndc": "0116-0767-16", "marketing_start_date": "20170101"}, {"sample": false, "description": "532 mL in 1 BOTTLE, PUMP (0116-0767-18)", "package_ndc": "0116-0767-18", "marketing_end_date": "20270131", "marketing_start_date": "20221114"}], "brand_name": "Antiseptic Skin Cleanser", "product_id": "0116-0767_457387bd-dcc2-ade6-e063-6394a90aa6b5", "dosage_form": "LIQUID", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "0116-0767", "generic_name": "CHLORHEXIDINE GLUCONATE 4%", "labeler_name": "Xttrium Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antiseptic Skin Cleanser", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "4 g/100mL"}], "application_number": "NDA019125", "marketing_category": "NDA", "marketing_start_date": "20110831", "listing_expiration_date": "20261231"}