FDA.reportPublic FDA data

Ipana Bucky Beaver Bubble Gum Childrens Fluoride

Product NDC
69510-020
11-digit product format
695100020
Labeler code
69510
Product ID
69510-020_3b02cda4-9b25-79c9-e063-6294a90af5b9
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE
Route
DENTAL
Labeler
Maxill Inc
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-31
Marketing end
2027-01-31
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
.1 g/100g
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Ipana Bucky Beaver Bubble Gum Childrens Fluoride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e7aa2a8d-7140-4718-bf69-917bb50d32c7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69510-020-19Ipana Bucky Beaver Bubble Gum Childrens Fluoride1 in 1 BOXPASTE19
69510-020-19Ipana Bucky Beaver Bubble Gum Childrens Fluoride19 g in 1 TUBEPASTE199

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QIPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OIPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPIPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]1
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XIPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9IPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYIPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JIPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]1
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZIPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RIPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]1
WATERINACTIVE INGREDIENT059QF0KO0RIPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69510-020IPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC]8Current NDC, Legacy NDC, 2 package rows20241018_e7aa2a8d-7140-4718-bf69-917bb50d32c7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 40 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHITE GLO PROFESSIONAL CHOICESODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC13314c9a-de93-4f54-b703-b5cebdf1e6aa2025-02-26WarningsExact identifier
application number: M021
WHITE GLO CHARCOALSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCa14bb838-f07a-3a6f-e053-2995a90a535d2025-02-26WarningsExact identifier
application number: M021
White Glo Maximum White CharcoalSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f64d2-969f-7ac1-e053-2995a90a627b2025-02-26WarningsExact identifier
application number: M021
White Glo Instant WhiteSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f0-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Instant White Blue Foam Optical Enhancers Fluoride Anticavity Value 2 pack and ToothbrushSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC7c15eedb-d4ca-4fc1-8a1e-6f9cad0cc1262025-02-26WarningsExact identifier
application number: M021
White Glo Mouthwash ProtectionSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCce4f0f8f-46f1-b4e6-e053-2a95a90af6c62025-02-26WarningsExact identifier
application number: M021
White Glo Professional White AntiCavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC1fb04108-31b3-43dd-9509-bfa8461135162025-02-26WarningsExact identifier
application number: M021
White Glo Activated Charcoal Twin PackSODIUM FLUORIDEWHITE GLO USA INC6adaca4f-5599-41e0-9215-c7ee5c1dc3722025-02-26WarningsExact identifier
application number: M021
White Glo Professional Choice Twin PackSODIUM FLUORIDEWHITE GLO USA INC0c913e38-e655-7208-e063-6294a90a58c92025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Fluoride PurpleSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb25aa35b-98ce-4605-a7b1-8c2fe476e1a82025-02-26WarningsExact identifier
application number: M021
White Glo Coffee and Tea Stain Remover Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCd69387f9-03b8-4551-a814-20606500af282025-02-26WarningsExact identifier
application number: M021
White Glo Advantage Anticavity Professional WhiteningSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC164c3e87-74e5-4128-9bd7-60e162e589842025-02-26WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Mint ShieldSODIUM FLUORIDEKenvue Brands LLC2e01b69a-b8f7-f2b9-e063-6294a90af3882025-02-13WarningsExact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse Bubble BlastSODIUM FLUORIDEKenvue Brands LLC2e021015-bb43-482b-e063-6294a90a69022025-02-13WarningsExact identifier
application number: M021
ZONSEN Gel FluorideGEL FLUORIDE TOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c1e40c9-8314-46ac-e063-6294a90a84ba2025-02-11WarningsExact identifier
application number: M021
ZONSEN Toothpaste,whiteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.2c3349bf-710b-fb84-e063-6394a90a3cc72025-02-11WarningsExact identifier
application number: M021
DawnMistTOOTHPASTEDukal LLC147f7738-5080-9907-e063-6294a90a61702025-02-07WarningsExact identifier
application number: M021
DawnMist Gel FluorideGEL FLUORIDE TOOTHPASTEDukal LLC14443184-1694-70b9-e063-6394a90a86fe2025-02-07WarningsExact identifier
application number: M021
Quip Anticavity Fluoride ConcentrateSODIUM FLUORIDEQuip NYC Inc.b3da65bb-0871-34e7-e053-2a95a90a310e2025-01-30WarningsExact identifier
application number: M021
Quip AnticavitySODIUM FLUORIDEQuip NYC Inc.b6d4cfe3-535e-9163-e053-2a95a90ae1402025-01-30WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNe7aa2a8d-7140-4718-bf69-917bb50d32c79
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDe7aa2a8d-7140-4718-bf69-917bb50d32c79
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYe7aa2a8d-7140-4718-bf69-917bb50d32c79
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYe7aa2a8d-7140-4718-bf69-917bb50d32c79
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYe7aa2a8d-7140-4718-bf69-917bb50d32c79
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYe7aa2a8d-7140-4718-bf69-917bb50d32c79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69510-020-19695100020191 TUBE in 1 BOX (69510-020-19) / 19 g in 1 TUBE1 tube2015-01-052027-01-31NoNoCurrent