FDA.reportPublic FDA data

parodontax

Product NDC
0135-0638
11-digit product format
001350638
Labeler code
0135
Product ID
0135-0638_7483472a-9e10-436c-aa9f-abe78b3f2d75
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
2022-01-03
Substance
STANNOUS FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
parodontax
Brand name suffix
Active Gum Repair Whitening
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
817e804c-e55e-4d77-9ab9-ff54ae794725Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0638-03parodontaxActive Gum Repair Whitening1 in 1 CARTONPASTE15
0135-0638-03parodontaxActive Gum Repair Whitening65.2 g in 1 TUBEPASTE65.25
0135-0638-04parodontaxActive Gum Repair Whitening1 in 1 CARTONPASTE15
0135-0638-04parodontaxActive Gum Repair Whitening96.4 g in 1 TUBEPASTE96.45
0135-0638-06parodontaxActive Gum Repair Whitening96.4 g in 1 TUBEPASTE96.45
0135-0638-06parodontaxActive Gum Repair Whitening2 in 1 CARTONPASTE25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0638PARODONTAX ACTIVE GUM REPAIR WHITENING (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 6 package rows20250424_817e804c-e55e-4d77-9ab9-ff54ae794725.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 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsExact identifier
application number: M022
Ollie Fresh MintSODIUM FLUORIDE, POTASSIUM NITRATEBrio Product Group LLC.ebeec44f-3c22-43f2-9256-6ece6025c1052026-08-06WarningsExact identifier
application number: M022
PRO-SYSORAL WOUND CLEANSERForward Science Technologies LLCc357c8f8-6fd6-c2f8-e053-2995a90a40232026-07-30WarningsExact identifier
application number: M022
Lornamead Natural WhiteFLUORIDELornamead Products9d7d08d7-8ca4-4b05-8b74-3bfa372b16082026-07-29WarningsExact identifier
application number: M022
Made by Dentists Enamel 10 Fluoride AnticavityPOTASSIUM NITRATE, SODIUM FLUORIDEMade By Dentists Inc3c62eab1-0cb6-4bdf-bfd4-c5afe734d0362026-07-24WarningsExact identifier
application number: M022
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
application number: M022
Good Neighbor Sore Throat Cherry FlavorPHENOLAMERISOURCE BERGENaa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f2026-07-13WarningsExact identifier
application number: M022
ABC Sore Throat Menthol FlavorPHENOLAMERISOURCE BERGEN9d9baf58-4790-4ff4-a462-5eb70c0e80c52026-07-13WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEP & L Development, LLC350b5f64-d152-40cb-b22f-98541f0e1b0a2026-07-09WarningsExact identifier
application number: M022
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC561a75c2-a40c-ba7c-e063-6294a90aa1192026-07-08WarningsExact identifier
application number: M022
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-07-06WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-07-03WarningsExact identifier
application number: M022
Dental system starter kitUS CONVENIENCE KIT (718907)Dyson Technology Limited5355b79b-711f-1a4a-e063-6394a90afc4b2026-06-30WarningsExact identifier
application number: M022
Anticavity and sensitive peppermint907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINTDyson Technology Limited5332ab71-d994-39cf-e063-6294a90a0d982026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
application number: M022
CorinzCETYLPYRIDINIUM CHLORIDESage Products, LLC685b6023-89c4-417e-af2d-52e831855da12026-06-29WarningsExact identifier
application number: M022
Antiplaque solutionCETYLPYRIDINIUM CHLORIDESage Products LLC881d4d08-4b45-486a-93af-18c0e00a5b0e2026-06-29WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN817e804c-e55e-4d77-9ab9-ff54ae7947255
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD817e804c-e55e-4d77-9ab9-ff54ae7947255
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY817e804c-e55e-4d77-9ab9-ff54ae7947255
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY817e804c-e55e-4d77-9ab9-ff54ae7947255
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY817e804c-e55e-4d77-9ab9-ff54ae7947255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0638-03001350638031 TUBE in 1 CARTON (0135-0638-03) / 65.2 g in 1 TUBE1 tube2022-01-030000-00-00NoNoCurrent
0135-0638-04001350638041 TUBE in 1 CARTON (0135-0638-04) / 96.4 g in 1 TUBE1 tube2022-01-030000-00-00NoNoCurrent
0135-0638-06001350638062 TUBE in 1 CARTON (0135-0638-06) / 96.4 g in 1 TUBE2 tube2025-04-01NoNoCurrent