FDA.reportPublic FDA data

SEXYTEETH MINTY T00THPASTE

Product NDC
85215-004
11-digit product format
852150004
Labeler code
85215
Product ID
85215-004_51d27efb-8ac9-fed7-e063-6294a90ab0f1
Type
HUMAN OTC DRUG
Nonproprietary name
SEXYTEETH MINTY Toothpaste
Dosage form
OINTMENT
Route
DENTAL
Labeler
WORLD DENTISTS ASSOCIATION AMERICA LIMITED
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-15
Substance
SODIUM FLUORIDE
Active strength
.24 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
SEXYTEETH MINTY T00THPASTE
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
51d288c1-fe86-ffe1-e063-6394a90ab4c4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85215-004-01SEXYTEETH MINTY T00THPASTE113 g in 1 TUBEOINTMENT1131

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 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN51d288c1-fe86-ffe1-e063-6394a90ab4c41
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD51d288c1-fe86-ffe1-e063-6394a90ab4c41
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY51d288c1-fe86-ffe1-e063-6394a90ab4c41
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY51d288c1-fe86-ffe1-e063-6394a90ab4c41
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY51d288c1-fe86-ffe1-e063-6394a90ab4c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85215-004-0185215000401113 g in 1 TUBE (85215-004-01) 113 g2026-05-15NoNoCurrent