Prescription Drug Information: Topical Fluoride Foam Bumble Bee Bubble Gum

TOPICAL FLUORIDE FOAM BUMBLE BEE BUBBLE GUM — sodium fluoride and hydrofluoric acid aerosol
Laclede, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Topical Fluoride Foam

Acidulated Phosphate Fluoride Solution Containing 1.23% w/w Fluoride ion


Description: Topical Fluoride Foam is a flavored aqueous foaming solution of acidulated phosphate

sodium fluoride with pH of 3.5 and a fluoride ion concentration of 1.23% w/w.

Active Ingredients: Sodium Fluoride and Hydrofluoric Acid (equivalent to 1.23% w/w Fluoride ion).

Inactive Ingredients
: Purified Water, poloxamer 407, isobutane, poloxamer 234, phosphoric acid,
sodium saccharin, flavor.

Fluoride Foam

Image of Label
(click image for full-size original)
acidulated phosphate fluoride aerosol
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54897-507
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride ion) Fluoride ion 10 mg in 1 g
Hydrofluoric Acid (Fluoride ion) Fluoride ion 2.3 mg in 1 g
Product Characteristics
Color Score
Shape Size
Flavor BUBBLE GUM (Bubble Gum Flavor) Imprint Code
# Item Code Package Description Multilevel Packaging
1 NDC:54897-507-17 165 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/04/2000
Labeler — Laclede, Inc. (098835994)

Revised: 03/2011 Laclede, Inc. provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.