FDA.reportPublic FDA data

Made by Dentists Ultra Whitening Fresh Mint

Product NDC
75065-027
11-digit product format
750650027
Labeler code
75065
Product ID
75065-027_5cca000f-3162-6a77-e063-6394a90a0d99
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE
Route
DENTAL
Labeler
MADE BY DENTISTS INC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-22
Substance
SODIUM FLUORIDE
Active strength
1.5 mg/g
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
Made by Dentists Ultra Whitening Fresh Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 mg/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75065-027-06Made by Dentists Ultra Whitening Fresh Mint120 g in 1 TUBEPASTE1202
75065-027-06Made by Dentists Ultra Whitening Fresh Mint1 in 1 CARTONPASTE12
75065-027-07Made by Dentists Ultra Whitening Fresh Mint1 in 1 CARTONPASTE12
75065-027-07Made by Dentists Ultra Whitening Fresh Mint20 g in 1 TUBEPASTE202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75065-027MADE BY DENTISTS ULTRA WHITENING FRESH MINT (SODIUM FLUORIDE) PASTE [MADE BY DENTISTS INC]2Current NDC, 4 package rows20240316_dbce2aba-48db-4e78-bf79-74f34868ee37.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 45 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companycef9a30c-a18c-47e9-b276-f56608f0400f2024-10-01WarningsExact identifier
application number: M021
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company86c4b51e-b086-4566-8f94-a951bf0c62542024-09-30WarningsExact identifier
application number: M021
Colgate Total Whitening Fresh BoostSTANNOUS FLUORIDEColgate-Palmolive Companyc436382e-2755-c882-2970-4be1b9ca537b2024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Whitening GelSTANNOUS FLUORIDEColgate-Palmolive Company27c4eed5-9121-4e09-9d42-e0a3e84301092024-09-30WarningsExact identifier
application number: M021
Colgate Total Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company56434e3d-ba0a-8b42-6c97-0d00556067932024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Mint Stripe GelSTANNOUS FLUORIDEColgate-Palmolive Companyabfbcacd-9c1a-4472-9e91-a85e78050a9e2024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyf8aeac8e-6a3e-4ada-bb13-db337b934ba32024-09-27WarningsExact identifier
application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDECVS Pharmacy, Inc.4a68bd30-91d3-46c9-a3d4-4fe342b5e6ef2024-09-27WarningsExact identifier
application number: M021
Colgate Total SF Advanced Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company92642408-4465-4f8f-85f9-cf12aadc147b2024-09-27WarningsExact identifier
application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVORSODIUM FLUORIDEAshtel Studios Inc.b197ac2d-f9d6-4937-a0a6-2f425e4c37962024-09-26WarningsExact identifier
application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVORSODIUM FLUORIDEAshtel Studios, Incdc04ee5c-3561-4579-8f9b-00266a8c88712024-09-25WarningsExact identifier
application number: M021
Made by Dentists For Kids Cheetah Dust (Strawberry)SODIUM FLUORIDEMADE BY DENTISTS INC94939abe-b05e-4ea2-a1a6-204da857b4aa2024-09-18WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Arctic BlastSODIUM FLUORIDEChattem, Inc.2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c572024-08-22WarningsExact identifier
application number: M021
CinnaFreshSODIUM FLUORIDEBob Barker Company Inc.3fbd95f0-a10c-4351-ad80-7e90b2d6a6f52024-08-22WarningsExact identifier
application number: M021
Karl and Hans Botanic Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATIONd1233fc3-047c-4e26-bb2b-8ebde09c05a92024-08-08WarningsExact identifier
application number: M021
Karl and Hans Botanic JasmineSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION6c0335e6-f041-48c7-9da3-88c124b84b002024-08-08WarningsExact identifier
application number: M021
OMNISTANNOUS FLUORIDESolventum US LLC0c2a81b1-65b5-432b-8e66-30432a245aba2024-08-01WarningsExact identifier
application number: M021
Just For KidsSTANNOUS FLUORIDESolventum US LLC0f1afc36-f699-4072-b90b-c9f5be989a492024-08-01WarningsExact identifier
application number: M021
Clinpro Tooth CremeSODIUM FLUORIDESolventum US LLC786c6184-6bc8-4376-9ce2-3e35af1932102024-08-01WarningsExact identifier
application number: M021
PerioMedSTANNOUS FLUORIDESolventum US LLC7f79eb00-86df-4284-b415-47f45e4849da2024-08-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNdbce2aba-48db-4e78-bf79-74f34868ee372
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDdbce2aba-48db-4e78-bf79-74f34868ee372
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYdbce2aba-48db-4e78-bf79-74f34868ee372
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYdbce2aba-48db-4e78-bf79-74f34868ee372
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYdbce2aba-48db-4e78-bf79-74f34868ee372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75065-027-06750650027061 TUBE in 1 CARTON (75065-027-06) / 120 g in 1 TUBE1 tube2024-02-22NoNoCurrent
75065-027-07750650027071 TUBE in 1 CARTON (75065-027-07) / 20 g in 1 TUBE1 tube2024-02-22YesNoCurrent