NDC 0135-0591 Aquafresh Extra Fresh Plus Whitening
Sodium Fluoride Paste Dental

Product Information

What is NDC 0135-0591?

The NDC code 0135-0591 is assigned by the FDA to the product Aquafresh Extra Fresh Plus Whitening which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Aquafresh Extra Fresh Plus Whitening is sodium fluoride. The product's dosage form is paste and is administered via dental form. The product is distributed in 2 packages with assigned NDC codes 0135-0591-01 1 tube in 1 carton / 158.8 g in 1 tube, 0135-0591-02 1 tube in 1 carton / 85.1 g in 1 tube. 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 Code0135-0591
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.		Aquafresh Extra Fresh Plus Whitening
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Sodium Fluoride
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Sodium Fluoride
Product Type 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.		Human Otc Drug
Dosage FormPaste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Dental - Administration to a tooth or teeth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0135
FDA Application Number 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.		part355
Marketing Category 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.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
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.		05-09-2014
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.		12-31-2023
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". 		N
NDC Code Structure

What are the uses for Aquafresh Extra Fresh Plus Whitening?


Product Characteristics

Flavor(s)MINT (C73404 - COOL MINT)
MINT (C73404 - FRESH MINT)

Product Packages

NDC Code 0135-0591-01

Package Description: 1 TUBE in 1 CARTON / 158.8 g in 1 TUBE

NDC Code 0135-0591-02

Package Description: 1 TUBE in 1 CARTON / 85.1 g in 1 TUBE

Product Details

What are Aquafresh Extra Fresh Plus Whitening Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Aquafresh Extra Fresh Plus Whitening 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:

Aquafresh Extra Fresh Plus Whitening 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.

Patient Education

Fluoride


Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
[Learn More]


* Please review the disclaimer below.

Aquafresh Extra Fresh Plus Whitening 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 (Cavity Protection, Extra Fresh +Whitening, Multi Action Whitening)



Sodium fluoride 0.25% (0.15% w/v fluoride ion)


Active Ingredient (Ultimate White)



Sodium fluoride 0.24% (0.15% w/v fluoride ion)


Purpose



Anticavity


Use



aids in the prevention of dental cavities


When Using This Product,



if irritation occurs discontinue use


Keep Out Of Reach Of Children Under 6 Years Of Age.



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


Directions



  • •adults and children 2 years and older:
    • •apply toothpaste onto a toothbrush 
    • •brush teeth thoroughly, preferably after each meal, or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • •to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
    • •children under 2 years of age: Consult a dentist or doctor

Other Information



  • •store below 30°C (86°F)

Inactive Ingredients (Cavity Protection)



water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1


Inactive Ingredients (Extra Fresh +Whitening)



water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1


Inactive Ingredients (Multi Action Whitening)



water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, cocamidopropyl betaine, sodium citrate, sodium saccharin, zinc chloride, red 30, blue 1


Inactive Ingredients (Ultimate White)



water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, titanium dioxide, flavor, xanthan gum, sodium hydroxide, sodium saccharin, red 30, blue 1


Questions



Call toll-free 1-800-897-5623


Principal Display Panel



NDC 0135-0590-01

  •  Aquafresh®

    • fluoride toothpaste

    triple protection®

    • •healthy gums*
    • •strong teeth
    • •fresh breath

      • cavity protection

      Sugar Acid Protection**

      from Fluoride

      cool mint

      NET WT 5.6 OZ (158.8 g)

      **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

      *with twice daily brushing

      ALWAYS FOLLOW THE LABEL

      Trademarks are owned by or licensed to the GSK group of companies.

      ©2015 GSK group of companies or its licensor. All rights reserved.

      GSK Consumer Healthcare

      Warren, NJ 07059

      Made in Taiwan

      1-800-897-5623

      105263XA

      NDC 0135-0591-01

      •  Aquafresh®

        • fluoride toothpaste

        triple protection®

        • •healthy gums*
        • •strong teeth
        • •fresh breath

          • extra fresh +whitening

          Sugar Acid Protection**

          from Fluoride

          fresh mint

          NET WT 5.6 OZ (158.8 g)

          **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

          *with twice daily brushing

          ALWAYS FOLLOW THE LABEL

          Trademarks are owned by or licensed to the GSK group of companies.

          ©2015 GSK group of companies or its licensor. All rights reserved.

          GSK Consumer Healthcare

          Warren, NJ 07059

          1-800-897-5623

          105282XA

          NDC 0135-0594-01

          •  Aquafresh®

            • fluoride toothpaste

            triple protection®

            WHITENING

            MULTI ACTION

            Sugar Acid Protection**

            from Fluoride

            NET WT 5.6 OZ (158.8 g)

            cavity protection

            healthy gums*

            breath

            great taste

            whitening†

            enamel

            Invigorating Mint

            cavity protection

            healthy gums*

            fresh breath

            great taste

            removes surface stains

            enamel strengthening

            **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shidl that protects the tooth surface against sugar acid attack.

            *with twice daily brushing

            †whitens by removing surface stains

            ALWAYS FOLLOW THE LABEL

            Trademarks are owned by or licensed to the GSK group of companies.

            ©2015 GSK group of companies or its licensor. All rights reserved.

            GSK Consumer Healthcare

            Warren, NJ 07059

            105384XA

            NDC 0135-0592-01

            •  Aquafresh®

              • fluoride toothpaste

              triple protection®

              ultimate white

              Sugar Acid Protection**

              from Fluoride

              with whitening action

              frost mint

              NET WT

              6.0 OZ (170.1 g)

              •  Aquafresh® Ultimate White toothpaste gently polishes your teeth, lifts away stains and helps to prevent new stains appearing.
              •  **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attach.
              •  healthy gums†
              •  strong teeth
              •  fresh breath
              •  †with twice daily brushing

                • ALWAYS FOLLOW THE LABEL

                Trademarks are owned by or licensed to the GSK group of companies.

                ©2015 GSK group of companies or its licensor. All rights reserved.

                GSK Consumer Healthcare, Warren, NJ 07059

                105287XA


* Please review the disclaimer below.