antiseptic skin cleanser (0116-1061)

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_6e62eb50-ebab-361e-e053-2991aa0aba6f

Product Type HUMAN OTC DRUG

Marketing Category NDA

Application Number NDA019125

Listing Expiration 2026-12-31

Marketing Start 2018-08-01

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

0301161061153

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

15 mL in 1 CARTON (0116-1061-15)

source: ndc

Packages (1)

0116-1061-15 15 mL in 1 CARTON (0116-1061-15)

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": "6e62eb50-ebab-361e-e053-2991aa0aba6f", "openfda": {"upc": ["0301161061153"], "unii": ["MOR84MUD8E"], "rxcui": ["211365"], "spl_set_id": ["6e62eb50-ebaa-361e-e053-2991aa0aba6f"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 CARTON (0116-1061-15)", "package_ndc": "0116-1061-15", "marketing_start_date": "20180801"}], "brand_name": "ANTISEPTIC SKIN CLEANSER", "product_id": "0116-1061_6e62eb50-ebab-361e-e053-2991aa0aba6f", "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": "20180801", "listing_expiration_date": "20261231"}