FDA.reportPublic FDA data

Polident

Product NDC
0135-0710
11-digit product format
001350710
Labeler code
0135
Product ID
0135-0710_10cf4244-39b6-3267-e063-6394a90a7025
Type
HUMAN OTC DRUG
Nonproprietary name
stannous fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-04
Substance
STANNOUS FLUORIDE
Active strength
1.5 mg/g
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
Polident
Brand name suffix
ProPartial
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
557eeb32-64f4-41e8-ada4-91bd39ae2920Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0710-01PolidentProPartial1 in 1 CARTONPASTE12
0135-0710-01PolidentProPartial96.4 g in 1 TUBEPASTE96.42
0135-0710-02PolidentProPartial65.2 g in 1 TUBEPASTE65.22
0135-0710-02PolidentProPartial1 in 1 CARTONPASTE12
0135-0710-03PolidentProPartial22.7 g in 1 TUBEPASTE22.72
0135-0710-03PolidentProPartial1 in 1 CARTONPASTE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0710POLIDENT PROPARTIAL (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]2Current NDC, Legacy NDC, 6 package rows20240208_557eeb32-64f4-41e8-ada4-91bd39ae2920.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 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
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN557eeb32-64f4-41e8-ada4-91bd39ae29202
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD557eeb32-64f4-41e8-ada4-91bd39ae29202
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY557eeb32-64f4-41e8-ada4-91bd39ae29202
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY557eeb32-64f4-41e8-ada4-91bd39ae29202
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY557eeb32-64f4-41e8-ada4-91bd39ae29202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0710-01001350710011 TUBE in 1 CARTON (0135-0710-01) / 96.4 g in 1 TUBE1 tube2021-01-040000-00-00NoNoCurrent
0135-0710-02001350710021 TUBE in 1 CARTON (0135-0710-02) / 65.2 g in 1 TUBE1 tube2021-01-040000-00-00NoNoCurrent
0135-0710-03001350710031 TUBE in 1 CARTON (0135-0710-03) / 22.7 g in 1 TUBE1 tube2021-01-040000-00-00NoNoCurrent