FDA.reportPublic FDA data

parodontax

Product NDC
0135-0601
11-digit product format
001350601
Labeler code
0135
Product ID
0135-0601_c8ed1491-d424-49f6-b49e-56a938dc7328
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
2016-12-19
Substance
STANNOUS FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct0135-0601IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0135-06010135-0601-01IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…

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
parodontax
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.1 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
0f07aa1a-97be-44af-92d8-a10777e24e0aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0601-012024-01-30C16284748780-1e4f33bdf-abcc-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0601-012023-02-10C16284748780-1e4f33bdf-abcc-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0601-012022-07-29C16284748780-1e4f33bdf-abcc-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0601-01parodontax96.4 g in 1 TUBEPASTE96.412
0135-0601-01parodontax1 in 1 CARTONPASTE112
0135-0601-02parodontax2 in 1 CARTONPASTE212
0135-0601-02parodontax96.4 g in 1 TUBEPASTE96.412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0601-01GM - Gram0135-06015d289d50-b9f3-49b2-b927-2e1009c691c512017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0601PARODONTAX (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]11Current NDC, Legacy NDC, 4 package rows20250424_0f07aa1a-97be-44af-92d8-a10777e24e0a.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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSODYNE Rapid ReliefSTANNOUS FLUORIDEHaleon US Holdings LLCf9589e7c-c5ca-4465-8d37-47ad6c69249f2024-03-06WarningsExact identifier
application number: M022
SENSODYNE Repair and Protect Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLC34260c69-d829-46c0-b12a-5136ee073ba12024-03-06WarningsExact identifier
application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTHPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC76adbccb-0812-4407-a6fc-a57e6f144fbb2024-03-05WarningsExact identifier
application number: M022
SENSODYNE Advanced WhiteningPOTASSIUM NITRATEHaleon US Holdings LLCa06e2549-3c4e-4818-b53e-1dea6828219f2024-03-04WarningsExact identifier
application number: M022
Sensodyne Extra Whitening Cool MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCc977f2c4-e0f3-44d2-aa7a-845f0583af3e2024-03-04WarningsExact identifier
application number: M022
Sensodyne Natural whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC911ac7e4-2b92-43d5-af0b-b5f741b088fb2024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Healthy WhitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCaca38560-2fd7-47be-9e93-2abc3214e8562024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Gently SoothingPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC5403ab67-532c-4bdf-9b06-07b1866f37f12024-03-04WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Active Shield Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCe8684615-f544-4871-b935-0a0f93639d7d2024-03-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC3dfa6827-3aae-4f19-93f6-2ded2faf2ddd2024-03-04WarningsExact identifier
application number: M022
Made by Dentists Sensitive and Whitening Fresh MintPOTASSIUM NITRATE, SODIUM FLUORIDEMADE BY DENTISTS INC0d379c26-69ff-4666-9ad5-7618f0bd139f2024-02-27WarningsExact identifier
application number: M022
Polident ProPartialSTANNOUS FLUORIDEHaleon US Holdings LLC557eeb32-64f4-41e8-ada4-91bd39ae29202024-02-07WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Daily ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCedffce4d-108b-4ffd-9adf-e12cb42ffddd2024-01-24WarningsExact identifier
application number: M022
Peppermint TwistFLUORIDECaldwell Health LLC4b28cdd1-0dba-42f5-a9e8-06d9e75b23962024-01-17WarningsExact identifier
application number: M022
The Natural Dentist Groovy GrapeFLUORIDECaldwell Consumer Health LLC087abbed-1f58-4b45-a76b-a950fa81c18c2024-01-16WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINPharma Nobis, LLCe42fccc2-1b4f-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M022
Sunmark Benzoin Compound TinctureBENZOIN RESINStrategic Sourcing Services LLC0c96d810-83dc-47d3-9a75-63a79feaad0a2023-12-19WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINHumco Holding Group, Inc.b33b5896-673b-498c-8a58-76ece8552f7a2023-12-15WarningsExact identifier
application number: M022
Povidone IodinePOVIDONE IODINE ORAL RINSE 0.5%Humco Holding Group, Inc.b83dbdd1-ff63-caf8-e053-2a95a90a57642023-12-15WarningsExact identifier
application number: M022
Moon Whitening Gel AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c556a29-a697-3a66-e063-6394a90abfee2023-12-12WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN0f07aa1a-97be-44af-92d8-a10777e24e0a12
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD0f07aa1a-97be-44af-92d8-a10777e24e0a12
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY0f07aa1a-97be-44af-92d8-a10777e24e0a12
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY0f07aa1a-97be-44af-92d8-a10777e24e0a12
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY0f07aa1a-97be-44af-92d8-a10777e24e0a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0601-01001350601011 TUBE in 1 CARTON (0135-0601-01) / 96.4 g in 1 TUBE1 tube2016-12-190000-00-00NoNoCurrent
0135-0601-02001350601022 TUBE in 1 CARTON (0135-0601-02) / 96.4 g in 1 TUBE2 tube2025-04-01NoNoCurrent