NDC 63104-003 Bentasil Sugar Free Eucalyptus Soft Texture

Product Information

What is NDC 63104-003?

The NDC code 63104-003 is assigned by the FDA to the product Bentasil Sugar Free Eucalyptus Soft Texture which is product labeled by Cloetta Italia S.r.l.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 63104-003-20 20 lozenge in 1 bag . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code63104-003
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Bentasil Sugar Free Eucalyptus Soft Texture
NDC Directory StatusINACTIVATED PRODUCT and excluded from NDC Directory
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Cloetta Italia S.r.l.
Labeler Code63104
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		04-01-2014
Listing Expiration Date 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.		12-31-2017
Exclude Flag 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". 		I
NDC Code Structure

What are the uses for Bentasil Sugar Free Eucalyptus Soft Texture?


Product Characteristics

Color(s)GREEN (C48329 - AQUA)
ShapeROUND (C48348)
Size(s)19 MM
Imprint(s)NONE
Score1
Flavor(s)MENTHOL (C73403 - EUCALYPTUS AND MENTHOL)

Product Packages

NDC Code 63104-003-20

Package Description: 20 LOZENGE in 1 BAG

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Bentasil Sugar Free Eucalyptus Soft Texture Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1537073 - eucalyptus oil 5.7 MG / menthol 5.8 MG Oral Lozenge
  • RxCUI: 1537073 - Eucalyptus oil 5.7 MG / menthol 5.8 MG Oral Lozenge
  • RxCUI: 1537079 - Bentasil Eucalyptus 5.8 MG / 5.7 MG Oral Lozenge
  • RxCUI: 1537079 - Eucalyptus oil 5.7 MG / menthol 5.8 MG Oral Lozenge [Bentasil Eucalyptus]
  • RxCUI: 1537079 - Bentasil Eucalyptus (menthol 5.8 MG / eucalyptus oil 5.7 MG) Oral Lozenge

Bentasil Sugar Free Eucalyptus Soft Texture Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Bentasil Sugar Free Eucalyptus Soft Texture Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient



Menthol 5.8mg

Eucalyptus oil 5.7mg


Purpose



Cough Suppressant,

Oral Anesthetic


Uses



•for the temporary relief of minor sore throat

•for the temporary relief of coughs due to a cold


Warnings



Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.


Ask A Doctor Before Use If You Have



•persistent or chronic cough such as occurs with smoking, asthma, or emphysema •cough accompanied by excessive phlegm (mucus)


When Using This Product



•do not exceed recommended dosage


Stop Use And Ask A Doctor If



•cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. •sore mouth does not improve in 7 days or irritation, pain or redness persists or worsens 


Directions



•adults and children 5 years and over: slowly dissolve one drop in the mouth. May be repeated every 2 hours as needed. 

•children under 5 years: ask a doctor


Other Information



• Phenylketonurics: Contains Phenylalanine (1.3) mg per drop. •3.2 calories per drop


Inactive Ingredients



•aspartame (contains phenylalanine), carnauba wax, citric acid, coconut and or palm kernel oil, flavor, gum arabic, maltitol, sorbitol, xylitol


Product Label



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* Please review the disclaimer below.