FDA.reportPublic FDA data

parodontax

Product NDC
0135-0627
11-digit product format
001350627
Labeler code
0135
Product ID
0135-0627_3dceeb8e-b90f-4f13-9b47-999695738b9b
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
2018-11-01
Substance
STANNOUS FLUORIDE
Active strength
1.1 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
parodontax
Brand name suffix
Complete Protection
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
59bb84d6-6fd3-4586-bccf-7dc45cbbb39cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0627-01parodontaxComplete Protection23 g in 1 TUBEPASTE238
0135-0627-01parodontaxComplete Protection1 in 1 CARTONPASTE18
0135-0627-02parodontaxComplete Protection96.4 g in 1 TUBEPASTE96.48
0135-0627-02parodontaxComplete Protection1 in 1 CARTONPASTE18
0135-0627-03parodontaxComplete Protection1 in 1 CARTONPASTE18
0135-0627-03parodontaxComplete Protection65.2 g in 1 TUBEPASTE65.28
0135-0627-04parodontaxComplete Protection23 g in 1 TUBEPASTE238
0135-0627-05parodontaxComplete Protection96.4 g in 1 TUBEPASTE96.48
0135-0627-05parodontaxComplete Protection2 in 1 CARTONPASTE28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0627-02GM - Gram0135-06275976a5b6-ebee-4cfa-8b5d-b4fca28d74cf12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0627PARODONTAX COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 9 package rows20250424_59bb84d6-6fd3-4586-bccf-7dc45cbbb39c.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 % ) ToothpastePSN59bb84d6-6fd3-4586-bccf-7dc45cbbb39c8
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD59bb84d6-6fd3-4586-bccf-7dc45cbbb39c8
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY59bb84d6-6fd3-4586-bccf-7dc45cbbb39c8
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY59bb84d6-6fd3-4586-bccf-7dc45cbbb39c8
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY59bb84d6-6fd3-4586-bccf-7dc45cbbb39c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0627-01001350627011 TUBE in 1 CARTON (0135-0627-01) / 23 g in 1 TUBE1 tube2020-04-010000-00-00NoNoCurrent
0135-0627-02001350627021 TUBE in 1 CARTON (0135-0627-02) / 96.4 g in 1 TUBE1 tube2018-11-010000-00-00NoNoCurrent
0135-0627-03001350627031 TUBE in 1 CARTON (0135-0627-03) / 65.2 g in 1 TUBE1 tube2020-01-060000-00-00NoNoCurrent
0135-0627-040013506270423 g in 1 TUBE (0135-0627-04) 23 g2022-12-010000-00-00NoNoCurrent
0135-0627-05001350627052 TUBE in 1 CARTON (0135-0627-05) / 96.4 g in 1 TUBE2 tube2025-04-01NoNoCurrent