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 42 · 822 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)584b38ce-d1ef-4ecc-a887-7c96e7f9669f2026-08-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreensfb93c7f6-e025-4cf2-9997-acfe9a0debdd2026-08-19WarningsExact identifier
application number: M022
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
application number: M022
Ludens Honey Licorice Throat DropsMENTHOLPrestige Brands Holdings, Inc.5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac2026-08-19WarningsExact identifier
application number: M022
Ludens Dual ReliefPECTIN AND MENTHOLPrestige Brands Holdings, Inc.d0213cb3-ec8e-40cc-82c9-694032f0490f2026-08-19WarningsExact identifier
application number: M022
CVS Health Sore Throat Fast Relief Oral AnestheticPHENOLCVS Pharmacy,Inc.4fb880db-2185-41ef-a5f9-8983a28d2c5b2026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat CherryPHENOLCVS Pharmacy,Inc.887c68e0-ff44-4bad-b360-56fb99ed9c452026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat Menthol FlavorPHENOLCVS PHARMACY,INC.665be058-b965-4b78-80b0-dd85241809322026-08-17WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEHarris Teeter, LLC7e5f175d-f0d6-4665-ac14-1873d6b99c802026-08-12WarningsExact identifier
application number: M022
Gingicaine Gel Variety PakGINGICAINE GEL VARIETY PAKGingi-Pak a Division of the Belport62ed4ff3-18f6-5c67-e053-2991aa0a77922026-08-11WarningsExact identifier
application number: M022
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
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.5868c5a1-273f-f023-e063-6394a90ac9d82026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58690bb5-9604-26a4-e063-6394a90afdbe2026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586918cf-7b13-5999-e063-6294a90a88a92026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586924a0-322d-5dc3-e063-6294a90a15562026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58692e90-de74-52d3-e063-6394a90a97022026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586937ae-46af-7066-e063-6294a90ae53e2026-08-06WarningsExact identifier
application number: M022
Freshness Blueberry Toothpaste100gFRESHNESS BLUEBERRY TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d1dba-87fc-b676-e063-6294a90a14702026-08-06WarningsExact 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