NDC 0135-0486 Sensodyne Pronamel Intensive Enamel Repair Extra Fresh
Potassium Nitrate And Sodium Fluoride Paste Oral

Product Information

What is NDC 0135-0486?

The NDC code 0135-0486 is assigned by the FDA to the UNFINISHED product Sensodyne Pronamel Intensive Enamel Repair Extra Fresh which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us). The generic name of Sensodyne Pronamel Intensive Enamel Repair Extra Fresh is potassium nitrate and sodium fluoride. The product's dosage form is paste and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0135-0486-01 1 tube in 1 carton / 96.4 g in 1 tube, 0135-0486-02 2 tube in 1 carton / 96.4 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 Code0135-0486
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.		Sensodyne Pronamel Intensive Enamel Repair Extra Fresh
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.		Potassium Nitrate And 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.		Potassium Nitrate; 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.
  • 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.		Glaxosmithkline Consumer Healthcare Holdings (us)
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.		part356
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
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.		11-29-2018
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
Unfinished Product What is an Unfinished Product?
Not Available		Yes
NDC Code Structure

What are the uses for Sensodyne Pronamel Intensive Enamel Repair Extra Fresh?


Product Characteristics

Color(s)WHITE (C48325)
Flavor(s)MINT (C73404 - CLEAN MINT)
MINT (C73404 - EXTRA FRESH)

Product Packages

NDC Code 0135-0486-01

Package Description: 1 TUBE in 1 CARTON / 96.4 g in 1 TUBE

NDC Code 0135-0486-02

Package Description: 2 TUBE in 1 CARTON / 96.4 g in 1 TUBE

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Product Details

What are Sensodyne Pronamel Intensive Enamel Repair Extra Fresh 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.

Sensodyne Pronamel Intensive Enamel Repair Extra Fresh 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: 1086243 - potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste
  • RxCUI: 1086243 - potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste
  • RxCUI: 1086243 - K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste
  • RxCUI: 1086243 - Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste

Sensodyne Pronamel Intensive Enamel Repair Extra Fresh 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.

Sensodyne Pronamel Intensive Enamel Repair Extra Fresh 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



Potassium nitrate 5%

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


Purpose



Antihypersensitivity

Anticavity


Uses



  • •builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • •aids in the prevention of dental cavities.

Warnings



Click here to enter Warnings


When Using This Product,



if irritation occurs discontinue use.


Stop Use And Ask A Dentist If



  • •the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • •pain/sensitivity still persists after 4 weeks of use.

Keep Out Of Reach Of Children.



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


Directions



  • •adults and children 12 years of age and older:
    • •apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    • •brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
    • •children under 12 years of age: Consult a dentist or doctor.

Other Information (Clean Mint, Extra Fresh)



store below 25°C (77°F)


Inactive Ingredients (Clean Mint)



water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, PVM/MA copolymer, sodium hydroxide


Inactive Ingredients (Extra Fresh)



water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, PVM/MA copolymer, sodium hydroxide


Questions Or Comments?



Call toll-free 1-866-844-2797


Principal Display Panel



New

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

CLEAN MINT

ACTIVELY REPAIRS WEAKENED ENAMEL*

NET WT 3.4 OZ (96.4 g)

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

*Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth.

PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

LOCKS IN MINERALS

FOR STRONG HEALTHY TEETH

Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future.

With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to:

  • •Actively repair acid-weakened enamel
  • •Lock in minerals to protect against the effects of acid wear
  • •Protect against cavities

    • Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

    ALWAYS FOLLOW THE LABEL

    Trademarks owned or licensed by GSK.

    ©2018 GSK or licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    106406XA

    NDC 0135-0486-01

    New

    SENSODYNE

    PRONAMEL

    INTENSIVE ENAMEL REPAIR

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    EXTRA FRESH

    ACTIVELY REPAIRS WEAKENED ENAMEL*

    NET WT 3.4 OZ (96.4 g)

    SENSODYNE

    PRONAMEL

    INTENSIVE ENAMEL REPAIR

    *Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth.

    PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

    LOCKS IN MINERALS

    FOR STRONG HEALTHY TEETH

    Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future.

    With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to:

    • •Actively repair acid-weakened enamel
    • •Lock in minerals to protect against the effects of acid wear
    • •Protect against cavities

      • Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

      ALWAYS FOLLOW THE LABEL

      Trademarks owned or licensed by GSK.

      ©2018 GSK or licensor.

      Distributed by:

      GSK Consumer Healthcare

      Warren, NJ 07059

      106407XA


* Please review the disclaimer below.