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 Identifiers#

Field, Values table
FieldValues
Unii3FTR44B32Q
Rxcui416784

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

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