antiseptic skin cleanser

Generic: chlorhexidine gluconate

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
Labeler xttrium laboratories, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

chlorhexidine gluconate 4 g/100mL

Manufacturer
Xttrium Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0116-1061
Product ID 0116-1061_3400d7b1-6a97-bae1-e063-6394a90a155f
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 01161061
Hyphenated Format 0116-1061

Supplemental Identifiers

RxCUI
211365
UPC
0011610610404
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 (source: ndc)
Application Number NDA019125 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 4 g/100mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (0116-1061-04)
source: ndc

Packages (1)

0116-1061-04 118 mL in 1 BOTTLE, PLASTIC (0116-1061-04)

Ingredients (1)

chlorhexidine gluconate (4 g/100mL)

Linked Drug Pages (3)

ANTISEPTIC SKIN CLEANSER ndc-match (0.9) ANTISEPTIC SKIN CLEANSER ndc-match (0.9) ANTISEPTIC SKIN CLEANSER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3400d7b1-6a97-bae1-e063-6394a90a155f", "openfda": {"upc": ["0011610610404"], "unii": ["MOR84MUD8E"], "rxcui": ["211365"], "spl_set_id": ["6e5e678f-3832-d201-e053-2a91aa0a5ea8"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (0116-1061-04)", "package_ndc": "0116-1061-04", "marketing_start_date": "20110831"}], "brand_name": "ANTISEPTIC SKIN CLEANSER", "product_id": "0116-1061_3400d7b1-6a97-bae1-e063-6394a90a155f", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "0116-1061", "generic_name": "Chlorhexidine Gluconate", "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"}