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 16 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuruNanda OxyfusionHYDROGEN PEROXIDEGURUNANDA, LLC3be317b9-a5d8-b198-e063-6394a90af9852025-11-11WarningsExact identifier
application number: M022
GuruNanda Oral Pain ReliefMENTHOLGURUNANDA, LLC3b8f3562-0e46-bea4-e063-6294a90adb712025-11-11WarningsExact identifier
application number: M022
TopCare Cherry FlavorPHENOLTOPCO ASSOCIATES, LLC5d3f0610-deb4-4180-ae19-2c65ed2f368b2025-11-10WarningsExact identifier
application number: M022
Topcare Sore Throat Menthol FlavorPHENOLTOPCO ASSOCIATES LLCfb1f2c11-2508-4985-bae5-7d547bd6aa232025-11-10WarningsExact identifier
application number: M022
Zilactin-BBENZOCAINEASCENT CONSUMER PRODUCTS, INC42eeb3d4-bac6-4e29-e063-6294a90a644d2025-11-06WarningsExact identifier
application number: M022
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLC106b6115-d043-4050-80c6-1d82456dea022025-11-06WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLC4c278122-2643-46bf-9e44-11985210a16e2025-11-06WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCfee9969d-ad1a-4f44-9741-a0a44c9e11282025-11-06WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDETarget Corporation0ddf9945-147d-4b25-98a6-4e9f12a4656f2025-11-05WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.e6a312e5-17ac-46f0-8723-4e40eeecd69f2025-11-04WarningsExact identifier
application number: M022
PEROXY SHIELD MOUTH SORE1.5% HYDROGEN PEROXIDEDental Technologies, Inc.a72e433b-1b7d-4a0c-e053-2995a90a30c42025-11-04WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.ae628766-25b7-4b4f-abb8-a43faf2f44b92025-11-04WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.719743f9-21fc-4568-b879-acdfa46394642025-11-04WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.ff0695a1-1d7d-4b51-97fd-689e56d914fe2025-11-04WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)f7edf75c-cdba-4dde-bfc5-a04af34759d32025-11-03WarningsExact identifier
application number: M022
7 Select Oral Pain Maximum Strength ReliefBENZOCAINE7-ELEVEN, INC.f170a570-1c50-4b9a-be16-9b01bf5eaa742025-10-31WarningsExact identifier
application number: M022
Oral Pain ReliefBENZOCAINE AND BENZALKONIUM CHLORIDEUniversal Distribution Center LLC18520f9b-4d35-1e9c-e063-6294a90aaa392025-10-30WarningsExact identifier
application number: M022
Iodent Oral AnalgesicBENZOCAINEUnited Exchange Corp.63902125-f8dc-0ada-e053-2991aa0a7ce52025-10-30WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEBETTER LIVING BRANDS, LLC3bded237-4d2c-4b38-bedc-267fdc3741942025-10-29WarningsExact 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