Drugplain

Antiseptic Mouth Rinse .92 mg/mL

EUCALYPTOL · MOUTHWASH · Perrigo Direct, Inc

2 Recalls on Record
Plain English

Eucalyptol mouth rinse is an over-the-counter antiseptic mouthwash used to help reduce bacteria in the mouth and freshen breath. It is applied by rinsing in the mouth as directed on the product label.

Key Facts

Brand Name
Antiseptic Mouth Rinse
Generic Name
EUCALYPTOL
NDC Code (Product)
50804-072
Manufacturer
Perrigo Direct, Inc
Strength
.92 mg/mL
Dosage Form
MOUTHWASH
Route
ORAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
08/15/2009

Recall History

2 Recalls on Record
Class III09/05/2023

Vi-Jon, LLC

Incorrect/Undeclared Excipients.

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

bursitis6 reports
platelet count decreased6 reports
pneumonia6 reports
neutrophil count decreased5 reports
white blood cell count decreased5 reports
alanine aminotransferase increased4 reports
blood alkaline phosphatase increased4 reports
gamma-glutamyltransferase increased4 reports
off label use4 reports
aspartate aminotransferase increased3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use helps control plaque that leads to gingivitis

Dosage & Administration

Directions adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow children under 12 years of age - consult a dentist or doctor this rinse is not intended to replace brushing or flossing

Warnings

Warnings for this product

Adverse Reactions

Adverse reaction *This product is manufactued or distributed by Kenvue, Inc., distributor of Original Listerine ® Antiseptic Mouthwash. DISTRIBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99 PLEASANTON, CA 94566-0009 ‡1-888-723-3929 LOVE IT OR IT'S ON US‡ Scan here for more information Empty & Replace Cap PLASTIC BOTTLE how2recycle.info DSP-TN-210091 DSP-MO-20087

Frequently Asked Questions

What is Antiseptic Mouth Rinse used for?

Eucalyptol mouth rinse is an over-the-counter antiseptic mouthwash used to help reduce bacteria in the mouth and freshen breath. It is applied by rinsing in the mouth as directed on the product label.

Is Antiseptic Mouth Rinse a controlled substance?

Antiseptic Mouth Rinse is not classified as a controlled substance by the DEA.

What is the generic name for Antiseptic Mouth Rinse?

The generic name for Antiseptic Mouth Rinse is EUCALYPTOL. There are 10 other brand versions of EUCALYPTOL.

What is the NDC code for Antiseptic Mouth Rinse .92 mg/mL?

The NDC (National Drug Code) for Antiseptic Mouth Rinse .92 mg/mL is 50804-072, listed by Perrigo Direct, Inc.

Product NDC

50804-072

Package NDC

50804-072-86

Other Eucalyptol Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)