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 20 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Mouth Sore ReliefBENZOCAINEWalgreens253d7ea2-e48e-c7d7-e063-6394a90ae0012025-08-12WarningsExact identifier
application number: M022
Charm Tex FLUORIDE GelSODIUM FLUORIDEYangzhou Hongshengding Chemical Co.,Ltd.897b0102-1c96-4699-908e-a7b7e26cd29f2025-08-08WarningsExact identifier
application number: M022
Meijer Enamel GuardPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer Distribution Inc82bc95be-0a07-3f00-e053-2a91aa0a74382025-08-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLCac398ff0-0010-4e13-8b89-dc986fd7f9742025-08-08WarningsExact identifier
application number: M022
QUALITY CHOICE SALINEPLUS SOOTHING ALOEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)4ae4e88a-aaa5-4195-bedc-622fd5cd93942025-07-30WarningsExact identifier
application number: M022
Aseptil RojoPHENOLMenper Distributors, Inc.62c96dc1-4698-43c1-8e6d-f4062dc5eea22025-07-22WarningsExact identifier
application number: M022
AnestenkaBENZOCAINEMenper Distributors, Inc00a3f1bc-ddfe-47c6-8221-f48f915135032025-07-22WarningsExact identifier
application number: M022
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
application number: M022
SprinJene Natural Sensitivity and GumPOTASSIUM NITRATEHealth and Natural Beauty USA Corp3cb23e36-0e8c-4172-b4ae-859b58a2739f2025-07-07WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Berry TwistSODIUM FLUORIDEHaleon US Holdings LLC69c07c36-b5e0-420b-ab29-7d10913863222025-07-03WarningsExact identifier
application number: M022
DenTek Instant Pain Relief Maximum StrengthBENZOCAINEDenTek Oral Care, Inc.ae92b76e-815a-4b4c-8128-bd045098caa52025-06-30WarningsExact identifier
application number: M022
Sensodyne Clinical White Stain ProtectorPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC99037e59-53d6-492c-8fce-67641fc8efdd2025-06-25WarningsExact identifier
application number: M022
Iolite-SBENZOCAINEDharma Research, Inc.b3b68914-2adc-4f07-9521-0b18756be5222025-06-14WarningsExact identifier
application number: M022
Red Cross ToothacheEUGENOLThe Mentholatum Company3537e599-65d9-48d6-8a46-d42312f71e842025-06-11WarningsExact identifier
application number: M022
QUALITY CHOICE Sore ThroatPHENOLCHAIN DRUG MARKETING ASSOCIATIONc95ee086-f384-475d-ad0c-75518cb9d2fe2025-06-10WarningsExact identifier
application number: M022
Onral Oral Pain Reliever MouthwashBENZOCAINESyka Pharma Inc.5dd8d933-6f32-4eaf-8eca-9365d7de55a22025-06-03WarningsExact identifier
application number: M022
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC9e1f7462-a052-4db4-bc59-cce437b695d02025-05-20WarningsExact identifier
application number: M022
Saline 1.5 FL OZSALINEALAINA HEALTHCARE PRIVATE LIMITEDf1bdbb25-6943-4828-9ae0-7d9783c18b5f2025-05-19WarningsExact 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