ARU GUM HEALTH

Product NDC
70108-288
11-digit product format
701080288
Labeler code
70108
Product ID
70108-288_e245c687-e34c-4972-8cc6-1a3203613ce6
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Ashtel Studios, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-12
Substance
STANNOUS FLUORIDE
Active strength
.11 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
ARU GUM HEALTH
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.11 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-288-01ARU GUM HEALTH99 g in 1 TUBEPASTE, DENTIFRICE992
70108-288-01ARU GUM HEALTH1 in 1 BOXPASTE, DENTIFRICE12

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 3 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SprinJene White BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp8c401bea-0148-46a0-bbb3-80c17f9e8e3e2026-08-14WarningsExact identifier
application number: M021
ULTRA BRITE Baking Soda and Peroxide Whitening Cool MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company2b123d70-4f7d-41b0-b48f-711999e97ee02026-08-13WarningsExact identifier
application number: M021
COLGATE STRAWBERRY BURSTSODIUM FLUORIDEColgate-Palmolive Companyd037f65c-3d22-4d2a-a0a9-3dcba2357ebd2026-08-13WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINTSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd954777-697a-4cc7-8f5f-b2caf357ef952026-08-13WarningsExact identifier
application number: M021
TOMS OF MAINE KIDS SILLY STRAWBERRYSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.e36ceb7a-9a29-41d8-8d08-a859e515f1f52026-08-13WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.08d7ed04-67a4-437a-82c5-496f9893c6c72026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED FRESH COOL PEPPERMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.27278b02-c4fd-4092-a632-a14e442f5a952026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED FRESH SPEARMINT ICESODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.59a6b9ac-c28b-4ec3-8231-f35054ce0eaf2026-08-10WarningsExact identifier
application number: M021
Toms Kids Watermelon WiggleSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.48eaafb6-99f4-5fd1-10fc-4ea35cbb2c622026-08-10WarningsExact identifier
application number: M021
AutoBrush kids bubblegumSODIUM FLUORIDELander Enterprises, LLC64b60e74-fceb-4de9-a966-73bf8dbd666c2026-08-10WarningsExact identifier
application number: M021
AutoBrush kids strawberrySODIUM FLUORIDELander Enterprises, LLC7e880d50-8aab-4d57-abc1-e900070f9a112026-08-10WarningsExact identifier
application number: M021
AutoBrush kids watermelonSODIUM FLUORIDELander Enterprises, LLC5cb5eb46-705c-4bb7-bef1-e93a598636fd2026-08-10WarningsExact identifier
application number: M021
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLC0e043431-9d87-478d-87f5-5aa8b0a932eb2026-08-10WarningsExact identifier
application number: M021
Willo Minty Mist Dye FreeSODIUM FLUORIDEWillo 32, Inc.3ee5b49e-ca9a-ece6-e063-6394a90a3d002026-08-10WarningsExact identifier
application number: M021
Willo Bubble TwistSODIUM FLUORIDEWillo 32 Inc36560d62-e901-1f93-e063-6394a90a28032026-08-10WarningsExact identifier
application number: M021
Willo Berry Splash Dye FreeSODIUM FLUORIDEWillo 32, Inc3ea91af9-2895-e530-e063-6394a90a39e52026-08-10WarningsExact identifier
application number: M021
Fluoride Mouth Rinse AnticavitySODIUM FLUORIDETarget Corporation3daf3cc3-585a-4bb2-9b56-7117d220ed382026-08-10Warnings, Adverse reactionsExact identifier
application number: M021
TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGOSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.19de1e71-ab94-415f-b66d-e5748dea83172026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE WINTERMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.d5e1396e-0253-4ec0-a9ff-b61bda70de352026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED COOL MILD MINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.de92408c-d401-47c3-94ee-fb6c080926512026-08-10WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNd8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDd8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYd8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYd8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYd8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70108-288-01701080288011 TUBE in 1 BOX (70108-288-01) / 99 g in 1 TUBE1 tube2026-01-12NoNoCurrent