FDA.reportPublic FDA data

Smile Paint

Product NDC
87245-001
11-digit product format
872450001
Labeler code
87245
Product ID
87245-001_456cf00c-b4c0-4320-9c5c-f04b5f33703c
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
KIT
Labeler
JABBER JAW KIDS TOOTHPASTE LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
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
Smile Paint
Listing expiration
2027-12-31

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
a7463b5c-53b2-4353-a5ea-800fbd7bd17dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87245-001-01Smile Paint1 in 1 KITKIT11

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 % ToothpastePSNa7463b5c-53b2-4353-a5ea-800fbd7bd17d1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDa7463b5c-53b2-4353-a5ea-800fbd7bd17d1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYa7463b5c-53b2-4353-a5ea-800fbd7bd17d1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYa7463b5c-53b2-4353-a5ea-800fbd7bd17d1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYa7463b5c-53b2-4353-a5ea-800fbd7bd17d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87245-001-01872450001011 KIT in 1 KIT (87245-001-01) * 113 g in 1 TUBE (87245-100-04) 1 kit2025-12-01NoNoCurrent