MedPath

Original Antiseptic

Basics 318.003/318AH-AI Antiseptic Mouthrinse

Approved
Approval ID

11bfc79f-ffba-45f9-82b2-a7c19b990bb2

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

Amazon.Com Services LLC

DUNS: 128990418

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

EUCALYPTOL, Menthol, Methyl salicylate, Thymol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72288-318
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
EUCALYPTOL, Menthol, Methyl salicylate, Thymol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (10)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
EUCALYPTOLActive
Quantity: 0.92 mg in 1 mL
Code: RV6J6604TK
Classification: ACTIB
MENTHOLActive
Quantity: 0.42 mg in 1 mL
Code: L7T10EIP3A
Classification: ACTIB
METHYL SALICYLATEActive
Quantity: 0.6 mg in 1 mL
Code: LAV5U5022Y
Classification: ACTIB
THYMOLActive
Quantity: 0.64 mg in 1 mL
Code: 3J50XA376E
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/15/2025

Principal display panel

amazon basics

Original

Antiseptic

Mouthwash

Antigingivitis / Antiplaque

Original

Compare to Original Listerine ® Antiseptic Mouthwash*

50.7 FL OZ (1.58 QT) 1.5 L

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/15/2025

Use

helps control plaque that leads to gingivitis

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 9/15/2025

ADVERSE REACTION

DISTRIBUTED BY: Amazon.com, Services, LLC

Seattle, WA 98109 1-877-485-0385

©2025 Amazon Basics Services LLC, or its affiliates.

All rights reserved.

www.amazon.com/amazonbasics

Made in USA with U.S. and foreign components.

DSP-TN-21091

DSP-MO-20087

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/15/2025

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/15/2025

Other information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/15/2025

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/15/2025

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Original Listerine Antiseptic Mouthwash.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/15/2025

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/15/2025

Purpose

Antigingivitis, Antiplaque

WARNINGS SECTION

LOINC: 34071-1Updated: 9/15/2025

Warnings

for this product

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/15/2025

Do Not Use

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/15/2025

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day 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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/15/2025

Stop use and ask a dentist if

gingivitis, bleeding, or redness persists for more than 2 weeks

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