NDC 55312-318 Antiseptic Mouth Rinse

Eucalyptol, Menthol, Methyl Salicylate, Thymol

NDC Product Code 55312-318

NDC 55312-318-86

Package Description: 1 L in 1 BOTTLE, PLASTIC

NDC Product Information

Antiseptic Mouth Rinse with NDC 55312-318 is a a human over the counter drug product labeled by Western Family Foods, Inc.. The generic name of Antiseptic Mouth Rinse is eucalyptol, menthol, methyl salicylate, thymol. The product's dosage form is mouthwash and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1043619.

Dosage Form: Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Antiseptic Mouth Rinse Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Western Family Foods, Inc.
Labeler Code: 55312
FDA Application Number: part356 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-14-1996 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Antiseptic Mouth Rinse Product Label Images

Antiseptic Mouth Rinse Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredientsEucalyptol 0.092%  Menthol 0.042%Methyl salicylate 0.060%   Thymol 0.034%

Otc - Purpose

PurposeAntigingivitis, antiplaque

Indications & Usage

Use helps control plaque that leads to gingivitis



Otc - Do Not Use

Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacingbetween the teeth.  See your dentist immediately.  These may be signs of periodontitis, a serious form of gum disease.

Otc - Stop Use

Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

Directionsadults 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 swallowchildren under 12 years of age - consult a dentist or a doctor• this rinse is not intended to replace brushing or flossing

Other Safety Information

Other information cold weather may cloud this product.  its antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

Inactive Ingredient

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


The ADA Council on Scientific Affairs Acceptance of Western Family Antiseptic Mouth Rinse is based on its finding that the product is effective to prevent and reduce gingivitis and plaque above the gumline, when used as directedThis product is not manufactured or distributed by Johnson + Johnson Healthcare Products distributor of Listerine

Adverse Reactions

Proudly Distributed byWestern Family Foods, Inc.P.O. Box 4057Portland, OR 97208 USAwww. westernfamily.com

* Please review the disclaimer below.