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Hibiclens

Chlorhexidine Gluconate · Solution

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Hibiclens
Generic name
Chlorhexidine Gluconate
Dosage form
Solution
Route
Topical
Marketing category
NDA · NDA
Labeler
Molnlycke Health Care
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
10
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Chlorhexidine Gluconate 4 g/100mL 1667684 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Topical
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Decreased Cell Wall Integrity [PE] PE All 26 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
017768
Application type
NDA · New Drug Application
Approval date
September 17, 1976
Sponsor
MOLNLYCKE HLTH
Products on application
1
Submissions recorded
40
Products approved under application 017768.
Product Trade name Form Strength Ingredient Status TE Flags
017768-001 HIBICLENS SOLUTION CHLORHEXIDINE GLUCONATE Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 017768.
Type No. Action Status Date Review
Supplement 63 Labeling Approved October 29, 2025 Standard
Supplement 59 Labeling Approved July 26, 2023 Standard
Supplement 60 Manufacturing (CMC) Approved June 22, 2023 N/A
Supplement 56 Labeling Approved February 11, 2022 Standard
Supplement 55 Manufacturing (CMC) Approved October 21, 2021 N/A
Supplement 49 Labeling Approved November 30, 2018 Standard
Supplement 48 Manufacturing (CMC) Approved August 10, 2018 N/A
Supplement 44 Labeling Approved October 17, 2017 Standard
Supplement 42 Manufacturing (CMC) Approved December 9, 2015 Priority
Supplement 41 Labeling Approved June 30, 2014 Standard
Supplement 39 Labeling Approved May 24, 2012 Standard
Supplement 33 Manufacturing (CMC) Approved July 2, 2002 Priority
Supplement 32 Manufacturing (CMC) Approved December 12, 2001 Priority
Supplement 31 Manufacturing (CMC) Approved February 23, 2000 Priority
Supplement 30 Manufacturing (CMC) Approved October 20, 1999 Priority
Supplement 29 Manufacturing (CMC) Approved September 30, 1998 Priority
Supplement 28 Manufacturing (CMC) Approved March 30, 1994 Priority
Supplement 25 Labeling Approved August 25, 1989 —
Supplement 26 Manufacturing (CMC) Approved July 18, 1989 Priority
Supplement 27 Manufacturing (CMC) Approved July 14, 1989 Priority
Supplement 24 Manufacturing (CMC) Approved May 11, 1988 Priority
Supplement 23 Labeling Approved March 3, 1988 —
Supplement 11 Labeling Approved May 20, 1987 —
Supplement 22 Manufacturing (CMC) Approved April 6, 1987 Priority
Supplement 19 Manufacturing (CMC) Approved May 9, 1985 Priority
Supplement 17 Manufacturing (CMC) Approved June 18, 1984 Priority
Supplement 2 Efficacy Approved March 1, 1982 —
Supplement 15 Manufacturing (CMC) Approved July 21, 1981 Priority
Supplement 5 Labeling Approved July 6, 1981 —
Supplement 14 Manufacturing (CMC) Approved March 10, 1981 Priority
Supplement 13 Manufacturing (CMC) Approved January 16, 1981 Priority
Supplement 12 Manufacturing (CMC) Approved December 29, 1980 Priority
Supplement 10 Manufacturing (CMC) Approved July 30, 1980 Priority
Supplement 7 Manufacturing (CMC) Approved December 18, 1979 Priority
Supplement 6 Manufacturing (CMC) Approved December 18, 1979 Priority
Supplement 8 Manufacturing (CMC) Approved July 25, 1979 Priority
Supplement 4 Manufacturing (CMC) Approved May 12, 1978 Priority
Supplement 3 Manufacturing (CMC) Approved January 6, 1978 Priority
Supplement 1 Manufacturing (CMC) Approved May 9, 1977 Priority
Original application 1 Type 2 - New Active Ingredient Approved September 17, 1976 Priority

Review documents

  • 0 · Supplement · November 3, 2025
  • 0 · Supplement · October 31, 2025
  • 0 · Supplement · July 31, 2023
  • 0 · Supplement · July 28, 2023
  • 0 · Supplement · June 23, 2023
  • 0 · Supplement · June 23, 2023
  • 0 · Supplement · February 15, 2022
  • 0 · Supplement · February 15, 2022
  • 0 · Supplement · January 24, 2022
  • 0 · Supplement · January 24, 2022
  • 0 · Supplement · December 30, 2018
  • 0 · Supplement · October 23, 2017
  • 0 · Supplement · October 19, 2017
  • 0 · Supplement · December 15, 2015
  • 0 · Supplement · July 31, 2014
  • 0 · Supplement · July 1, 2014
  • 0 · Supplement · May 29, 2012

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241223). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20241223 HUMAN OTC DRUG · 20241223

Indications and Usage

openFDA Drug Labeling

Uses antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease for skin wound and general skin cleansing surgical hand scrub healthcare personnel handwash patient preoperative skin preparation

Dosage and Administration

openFDA Drug Labeling

Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. skin wound and general skin cleansing . Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly. surgical hand scrub . Wet hands and forearms with water. Scrub for 3 minutes with about 5mL of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly. healthcare personnel handwash . Wet hands with water. Dispense about 5mL of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly. patient preoperative skin preparation . Apply the product liberally to surgical site and swab for at least 2 minutes. Dry with a sterile towel. Repeat.

Warnings

openFDA Drug Labeling

Warnings For external use only

Allergy alert: This product may cuase a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.

Do Not Use

openFDA Drug Labeling

Do not use if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product as a patient preoperative skin preparation of the head or face in contact with the meninges in the genital area

Ask a Doctor

openFDA Drug Labeling

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Active Ingredient

openFDA Drug Labeling

Chlorhexidine gluconate solution 4.0% w/v

Adverse event reports

Source: openFDA FAERS
9,457
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CHLORHEXIDINE GLUCONATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
76420-535-08 76420-535 Asclemed USA, Inc. 236 mL in 1 BOTTLE (76420-535-08) February 3, 2023
0234-0575-04 0234-0575 Molnlycke Health Care 118 mL in 1 BOTTLE (0234-0575-04) September 17, 1976
0234-0575-08 0234-0575 Molnlycke Health Care 236 mL in 1 BOTTLE (0234-0575-08) September 17, 1976
0234-0575-16 0234-0575 Molnlycke Health Care 473 mL in 1 BOTTLE (0234-0575-16) September 17, 1976
0234-0575-17 0234-0575 Molnlycke Health Care 50 PACKET in 1 CARTON (0234-0575-17) / 15 mL in 1 PACKET September 17, 1976
0234-0575-32 0234-0575 Molnlycke Health Care 946 mL in 1 BOTTLE (0234-0575-32) September 17, 1976
0234-0575-40 0234-0575 Molnlycke Health Care 118 mL in 1 BOTTLE (0234-0575-40) February 15, 2016
0234-0575-41 0234-0575 Molnlycke Health Care 118 mL in 1 BOTTLE, PUMP (0234-0575-41) February 1, 2019
0234-0575-80 0234-0575 Molnlycke Health Care 236 mL in 1 BOTTLE, PUMP (0234-0575-80) January 1, 2024
0234-0575-91 0234-0575 Molnlycke Health Care 3790 mL in 1 BOTTLE (0234-0575-91) September 17, 1976
76420-535 76420-535 Asclemed USA, Inc. — September 17, 1976
0234-0575 0234-0575 Molnlycke Health Care — September 17, 1976

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.