FDA.reportPublic FDA data

smart way MINT cavity protection

Product NDC
59450-010
11-digit product format
594500010
Labeler code
59450
Product ID
59450-010_3196ebf8-db21-4ae9-aa96-af5b47f5ce67
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
The Kroger Co.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-04
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
.13 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
smart way MINT cavity protection
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.13 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
45cc7a60-b4a7-4263-a114-f0d1f98a87fcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59450-010-01smart way MINT cavity protection119 g in 1 TUBEPASTE, DENTIFRICE1191
59450-010-01smart way MINT cavity protection1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-010SMART WAY MINT CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [THE KROGER CO.]1Current NDC, 2 package rows20250418_45cc7a60-b4a7-4263-a114-f0d1f98a87fc.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 20 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Cavity Protection Great Regular FlavorANTICAVITY FLUORIDE TOOTHPASTEColgate-Palmolive Company202c6c62-e16a-4716-babe-d5414006c79e2026-01-21WarningsExact identifier
application number: M021
Crest 3D White Luxe Diamond StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc1420129-5460-4900-ac9a-356d2d7c60a22026-01-21WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Max Cavity and Erosion PreventionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company48eb0bdc-7399-745d-e063-6294a90a98092026-01-21WarningsExact identifier
application number: M021
Colgate Total Gum Protect WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companydcf81dcb-b26b-4411-82d4-5f7e9d3fc0f32026-01-20WarningsExact identifier
application number: M021
GuruNanda Anti-CavitySODIUM FLUORIDEGURUNANDA, LLC3b07b72f-4efc-eb0f-e063-6294a90a70a82026-01-19WarningsExact identifier
application number: M021
GuruNanda AnticavitySODIUM FLUORIDEGURUNANDA, LLC3e90d516-3172-3c8d-e063-6294a90a394f2026-01-19WarningsExact identifier
application number: M021
HismilePEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0eba92d1-cbdc-9c96-e063-6294a90a9afc2026-01-15WarningsExact identifier
application number: M021
HismileCOCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef3cfb6-6bae-1682-e063-6394a90aca882026-01-15WarningsExact identifier
application number: M021
HismileMANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef3f4f8-fdc4-2056-e063-6394a90a6fd72026-01-15WarningsExact identifier
application number: M021
HismileSMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef41051-dfa0-b105-e063-6294a90a551f2026-01-15WarningsExact identifier
application number: M021
HismileWATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef43107-58ec-d4ee-e063-6294a90ad8d72026-01-15WarningsExact identifier
application number: M021
HismileRED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef56539-dc21-c6ea-e063-6394a90a57902026-01-15WarningsExact identifier
application number: M021
HismileGRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef6f8b5-8565-b364-e063-6294a90aabbc2026-01-15WarningsExact identifier
application number: M021
HismileSTRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef766ae-754a-f185-e063-6294a90a32992026-01-15WarningsExact identifier
application number: M021
HismileBANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef7be5b-df8f-9f32-e063-6394a90a47242026-01-15WarningsExact identifier
application number: M021
HismileVANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef8d0ef-a051-f610-e063-6394a90a85372026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d40b98b-2e9a-d84a-e063-6294a90a20962026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d44863e-93be-2b80-e063-6294a90a4a9d2026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d458ccc-8f1e-f9c8-e063-6294a90a8da42026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d447939-fbf6-42f6-e063-6294a90af6d92026-01-15WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN45cc7a60-b4a7-4263-a114-f0d1f98a87fc1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD45cc7a60-b4a7-4263-a114-f0d1f98a87fc1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY45cc7a60-b4a7-4263-a114-f0d1f98a87fc1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY45cc7a60-b4a7-4263-a114-f0d1f98a87fc1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY45cc7a60-b4a7-4263-a114-f0d1f98a87fc1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY45cc7a60-b4a7-4263-a114-f0d1f98a87fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59450-010-01594500010011 TUBE in 1 CARTON (59450-010-01) / 119 g in 1 TUBE1 tube2025-04-04NoNoCurrent