Drugplain

Antiseptic Mouth Rinse .92 mg/mL

Eucalyptol, Menthol, Methyol salicylate, Thymol · MOUTHWASH · Topco Associates LLC

2 Recalls on Record
Plain English

Antiseptic Mouth Rinse is a mouthwash containing eucalyptol, menthol, methyol salicylate, thymol at .92 mg/mL, taken oral. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
Antiseptic Mouth Rinse
Generic Name
Eucalyptol, Menthol, Methyol salicylate, Thymol
NDC Code (Product)
36800-072
Manufacturer
Topco Associates LLC
Strength
.92 mg/mL
Dosage Form
MOUTHWASH
Route
ORAL
Marketing Status
Application #
M017
Marketing Start
07/07/1995

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?

Antiseptic Mouth Rinse contains Eucalyptol, Menthol, Methyol salicylate, Thymol. It is a mouthwash taken oral. Consult your doctor for specific uses.

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, Menthol, Methyol salicylate, Thymol. There are no other listed brand versions of Eucalyptol, Menthol, Methyol salicylate, Thymol.

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 36800-072, listed by Topco Associates LLC.

Product NDC

36800-072

Package NDC

36800-072-12

Other Antiseptic Mouth Rinse Dosages

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

Data from openFDA · Public domain (CC0 1.0)