Eversmile Ipr Glide Gel
NDC 72655-400

View dosage, usage, ingredients, routes, and UNII mappings.

Product Information

Eversmile Ipr Glide (2.7% sodium fluoride gel) is a UNAPPROVED DRUG OTHER-approved product labeled by Everbrands, Inc. Dba Everpure, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a gel for dental administration. This product entry covers the primary NDC 72655-400 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
72655-400
Proprietary Name:
Eversmile Ipr Glide
Non-Proprietary Name: [1]
2.7% Sodium Fluoride Gel
Substance Name: [2]
Sodium Fluoride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s): [4]
Dental - Administration to a tooth or teeth.

Labeler & Regulatory Data

Labeler Code:
72655
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
04-10-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Flavor(s):

Code Structure Chart

Product Details

What is NDC 72655-400?

The NDC code 72655-400 is assigned by the FDA to the product Eversmile Ipr Glide. It is commonly known by its generic name, 2.7% sodium fluoride gel. This pharmaceutical product is labeled by Everbrands, Inc. Dba Everpure, Inc. and is currently categorized as listed product. The medication is a gel administered via dental route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 72655-400-01, 72655-400-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Directions For Use:IPR procedure: Dispense IPR Glide directly to theinterproximal tooth surfaces or to IPR cuttinginstruments. Perform IPR procedure and replenishIPR Glide as needed. Rinse teeth with water. Informpatient not to swallow IPR Glide.In-Office Post IPR Renewal: Rinse teeth with water,air dry and apply IPR Glide directly to teeth surfaceswhere IPR was performed. Have patient spit outexcess IPR Glide and inform patient to keep surfacesdry for 30 minutes avoiding food and liquids. Alignersmay be worn to prevent saliva contamination.At-home Post IPR Renewal: Apply IPR Glide insideof aligners at the location where IPR was performed.Your dentist can use a marker and indicate where toapply the IPR Glide. Place aligners in mouth and wipeoff any excess IPR Glide using a tissue. Allow IPR Glideto remain on teeth for 5-10 minutes, then removealigners and spit out any excess. Keep surfaces dryfor 30 minutes avoiding food and liquids.

What are Active Ingredients of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated 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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

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:

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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".