antiseptic skin cleanser (36800-401)

Drug Facts

Product Profile

Brand Name antiseptic skin cleanser

Generic Name chlorhexidine gluconate 4%

Labeler topco associates llc

Dosage Form LIQUID

Routes

TOPICAL

Active Ingredients

chlorhexidine gluconate 4 mg/100mL

Manufacturer

Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-401

Product ID 36800-401_45c4ec2b-ec70-57db-e063-6294a90a1b38

Product Type HUMAN OTC DRUG

Marketing Category NDA

Application Number NDA019125

Marketing Start 2013-11-01

Marketing End 2027-02-28

Pharmacologic Class

Classes

decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800401

Hyphenated Format 36800-401

Supplemental Identifiers

RxCUI

211365

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 mg/100mL

source: ndc

Packaging

237 mL in 1 BOTTLE, PLASTIC (36800-401-50)

source: ndc

Packages (1)

36800-401-50 237 mL in 1 BOTTLE, PLASTIC (36800-401-50)

Ingredients (1)

chlorhexidine gluconate (4 mg/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": "45c4ec2b-ec70-57db-e063-6294a90a1b38", "openfda": {"unii": ["MOR84MUD8E"], "rxcui": ["211365"], "spl_set_id": ["a0b7180a-0257-4a64-9d1a-6b6d824fac1c"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (36800-401-50)", "package_ndc": "36800-401-50", "marketing_end_date": "20270228", "marketing_start_date": "20131101"}], "brand_name": "Antiseptic Skin Cleanser", "product_id": "36800-401_45c4ec2b-ec70-57db-e063-6294a90a1b38", "dosage_form": "LIQUID", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "36800-401", "generic_name": "Chlorhexidine Gluconate 4%", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antiseptic Skin Cleanser", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "4 mg/100mL"}], "application_number": "NDA019125", "marketing_category": "NDA", "marketing_end_date": "20270228", "marketing_start_date": "20131101"}