NDC 69491-210 Delta Comfort Plus 2019 Amenity With Colgate Cavity Protection

Sodium Monofluorophosphate

NDC Product Code 69491-210

NDC Code: 69491-210

Proprietary Name: Delta Comfort Plus 2019 Amenity With Colgate Cavity Protection Additional informationCallout TooltipWhat 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.

Non-Proprietary Name: Sodium Monofluorophosphate Additional informationCallout TooltipWhat 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.


Code Structure
  • 69491 - Buzz Export Services Pty., Ltd.
    • 69491-210 - Delta Comfort Plus 2019 Amenity With Colgate Cavity Protection

NDC 69491-210-00

Package Description: 1 KIT in 1 KIT * 5 g in 1 TUBE (42555-060-94)

NDC Product Information

Delta Comfort Plus 2019 Amenity With Colgate Cavity Protection with NDC 69491-210 is a a human over the counter drug product labeled by Buzz Export Services Pty., Ltd.. The generic name of Delta Comfort Plus 2019 Amenity With Colgate Cavity Protection is sodium monofluorophosphate. The product's dosage form is kit and is administered via form.

Labeler Name: Buzz Export Services Pty., Ltd.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
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.

  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Buzz Export Services Pty., Ltd.
Labeler Code: 69491
FDA Application Number: part355 Additional informationCallout TooltipWhat 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat 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.

Start Marketing Date: 04-01-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Delta Comfort Plus 2019 Amenity With Colgate Cavity Protection Product Label Images

Delta Comfort Plus 2019 Amenity With Colgate Cavity Protection Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Helps protect against cavities

Keep Out Of The 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 of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years  use only apea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician

Inactive Ingredients

Dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

* Please review the disclaimer below.

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