NDC 72288-306 Alora Whitening

Potassium Nitrate And Sodium Fluoride

NDC Product Code 72288-306

NDC 72288-306-09

Package Description: 3 CARTON in 1 PACKAGE, COMBINATION > 1 TUBE in 1 CARTON (72288-306-08) > 28.35 g in 1 TUBE

NDC 72288-306-10

Package Description: 6 CARTON in 1 PACKAGE, COMBINATION > 1 TUBE in 1 CARTON (72288-306-08) > 28.35 g in 1 TUBE

NDC Product Information

Alora Whitening with NDC 72288-306 is a a human over the counter drug product labeled by Amazon, Inc. The generic name of Alora Whitening is potassium nitrate and sodium fluoride. The product's dosage form is gel, dentifrice and is administered via dental form.

Labeler Name: Amazon, Inc

Dosage Form: Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.

Product Type: Human Otc Drug 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.

Alora Whitening Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • POTASSIUM NITRATE 50 mg/g
  • SODIUM FLUORIDE 2.5 mg/g

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.

Labeler Name: Amazon, Inc
Labeler Code: 72288
FDA Application Number: part356 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 10-01-2019 What 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 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Alora Whitening Product Label Images