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_459d6c16-75f5-5ec0-e063-6394a90ac680

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

0011610611609 0001161061404 0011610613207 0301161061085

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

15142 mL in 1 JUG (0116-1061-01)
237 mL in 1 BOTTLE, PLASTIC (0116-1061-08)
437 mL in 1 BOTTLE, PLASTIC (0116-1061-16)
532 mL in 1 BOTTLE (0116-1061-18)
946 mL in 1 BOTTLE, PLASTIC (0116-1061-32)
118 mL in 1 BOTTLE (0116-1061-40)

source: ndc

Packages (6)

0116-1061-01 15142 mL in 1 JUG (0116-1061-01) 0116-1061-08 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) 0116-1061-16 437 mL in 1 BOTTLE, PLASTIC (0116-1061-16) 0116-1061-18 532 mL in 1 BOTTLE (0116-1061-18) 0116-1061-32 946 mL in 1 BOTTLE, PLASTIC (0116-1061-32) 0116-1061-40 118 mL in 1 BOTTLE (0116-1061-40)

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": "459d6c16-75f5-5ec0-e063-6394a90ac680", "openfda": {"upc": ["0011610611609", "0001161061404", "0011610613207", "0301161061085"], "unii": ["MOR84MUD8E"], "rxcui": ["211365"], "spl_set_id": ["9f6342f7-faa3-4d23-a860-054d04cb8d42"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15142 mL in 1 JUG (0116-1061-01)", "package_ndc": "0116-1061-01", "marketing_start_date": "20110831"}, {"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (0116-1061-08)", "package_ndc": "0116-1061-08", "marketing_start_date": "20110831"}, {"sample": false, "description": "437 mL in 1 BOTTLE, PLASTIC (0116-1061-16)", "package_ndc": "0116-1061-16", "marketing_start_date": "20110831"}, {"sample": false, "description": "532 mL in 1 BOTTLE (0116-1061-18)", "package_ndc": "0116-1061-18", "marketing_end_date": "20260831", "marketing_start_date": "20110831"}, {"sample": false, "description": "946 mL in 1 BOTTLE, PLASTIC (0116-1061-32)", "package_ndc": "0116-1061-32", "marketing_start_date": "20110831"}, {"sample": false, "description": "118 mL in 1 BOTTLE (0116-1061-40)", "package_ndc": "0116-1061-40", "marketing_start_date": "20190101"}], "brand_name": "ANTISEPTIC SKIN CLEANSER", "product_id": "0116-1061_459d6c16-75f5-5ec0-e063-6394a90ac680", "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"}