NDC Package 68016-318-77 Antiseptic Mouth Rinse

Eucalyptol,Menthol,Methyl Salicylate,Thymol Mouthwash Oral - View Billable Units, 11-Digit Format, RxNorm

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Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

68016-318-77

Package Description:

500 mL in 1 BOTTLE, PLASTIC

Product Code:

68016-318

Proprietary Name:

Antiseptic Mouth Rinse

Non-Proprietary Name:

Eucalyptol, Menthol, Methyl Salicylate, Thymol

Substance Name:

Eucalyptol; Menthol; Methyl Salicylate; Thymol

Usage Information:

Adult and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonsful) between teeth for 30 seconds then spit out, do not swallowchildren under 12 years of age - consult a dentist or doctorthis rinse is not intended to replace brushing or flossing

11-Digit NDC Billing Format:

68016031877

NDC to RxNorm Crosswalk:

RxCUI: 1043619 - eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash

RxCUI: 1043619 - eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash

Product Type:

Human Otc Drug

Labeler Name:

Chain Drug Consortium

Dosage Form:

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

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

EUCALYPTOL .92 mg/mL

MENTHOL .42 mg/mL

METHYL SALICYLATE .6 mg/mL

THYMOL .64 mg/mL

Sample Package:

FDA Application Number:

part356

Marketing Category:

OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.

Start Marketing Date:

08-19-2003

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

68016 - Chain Drug Consortium
- 68016-318 - Antiseptic Mouth Rinse
  - 68016-318-77 - 500 mL in 1 BOTTLE, PLASTIC

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
68016-318-86	1000 mL in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 68016-318-77?

The NDC Packaged Code 68016-318-77 is assigned to a package of 500 ml in 1 bottle, plastic of Antiseptic Mouth Rinse, a human over the counter drug labeled by Chain Drug Consortium. The product's dosage form is mouthwash and is administered via oral form.

Is NDC 68016-318 included in the NDC Directory?

Yes, Antiseptic Mouth Rinse with product code 68016-318 is active and included in the NDC Directory. The product was first marketed by Chain Drug Consortium on August 19, 2003 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 68016-318-77?

The 11-digit format is 68016031877. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	68016-318-77	5-4-2	68016-0318-77

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