FDA.reportPublic FDA data

evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINT

Product NDC
70108-254
Requested package NDC
70108-254-01
11-digit product format
701080254
Labeler code
70108
Product ID
70108-254_7d6234e9-f750-4688-8dc6-efcd5089922b
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Nitrate, Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Ashtel Studios, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Marketing end
2028-04-12
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .24 g/100g; 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
evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINT

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE.24 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-254-01evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINT99 g in 1 TUBEPASTE, DENTIFRICE991
70108-254-01evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINT1 in 1 BOXPASTE, DENTIFRICE11

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 24 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc37e2d51d-8526-4766-9f15-0ef4bc1f11552025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc1c0770a4-5a82-46d4-a660-7553632d749b2025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Incf1289991-c809-48cb-8bc1-724bc233dfe92025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Incf2a3a496-c9e0-4eb1-94cc-4c6c5fd60fee2025-01-09WarningsExact identifier
application number: M022
BurkhartSTANNOUS FLUORIDEBurkhart Dental Supply Inc6d8078e9-b0d8-4220-b90a-3f14fa0e43f42025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc26128466-939b-445f-aa64-04c7283d306c2025-01-09WarningsExact identifier
application number: M022
BurkhartSTANNOUS FLUORIDEBurkhart Dental Supply Inc048c9978-e32e-4f77-9a4e-40acd5fcdfaf2025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incaa09dcc0-e641-4c6d-8a84-ba890c0fce4c2025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc4255da05-d264-4a4c-bd67-53d4862c06822025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc2282ea74-94c1-40be-a77f-290763a762502025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc99bce4c6-4593-40a1-b28d-8334a79b9d422025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incaa233c68-c6ac-44a5-b50e-3f5cd843bd252025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incbb11bfb4-1b50-48c6-8273-452b47b478332025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc867cef7b-fe6e-4a45-87c1-35579a681c6c2025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incc6238079-0bcc-4c35-9b73-455252d41ee52025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incb144aca9-91d1-4106-a39c-b928192ad41e2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.0192ccf9-1715-4e23-a6bf-8bd838cd8b0d2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.edcb8451-6fa7-4bc2-95f6-2a0806f7f3da2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.576660ed-203a-4842-9d39-c5be10daf9762025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.1796b3ec-833a-4cf1-ba50-bc4da827f84f2025-01-09WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNbc74d2a6-fe34-44cf-b015-70ed4d47c9331
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDbc74d2a6-fe34-44cf-b015-70ed4d47c9331
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYbc74d2a6-fe34-44cf-b015-70ed4d47c9331
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYbc74d2a6-fe34-44cf-b015-70ed4d47c9331
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYbc74d2a6-fe34-44cf-b015-70ed4d47c9331
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYbc74d2a6-fe34-44cf-b015-70ed4d47c9331
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYbc74d2a6-fe34-44cf-b015-70ed4d47c9331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70108-254-01701080254011 TUBE in 1 BOX (70108-254-01) / 99 g in 1 TUBE1 tube2025-10-012028-04-12NoNoHistorical