FDA.reportPublic FDA data

SENSODYNE

Product NDC
0135-5024
11-digit product format
001355024
Labeler code
0135
Product ID
0135-5024_13123f95-ce72-c317-e063-6394a90ac2d2
Type
HUMAN OTC DRUG
Nonproprietary name
stannous fluoride
Dosage form
PASTE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-06
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
SENSODYNE
Brand name suffix
Sensitivity and Gum 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
0135-5024-01SENSODYNESensitivity and Gum Whitening1 in 1 CARTONPASTE16
0135-5024-01SENSODYNESensitivity and Gum Whitening96.4 g in 1 TUBEPASTE96.46
0135-5024-02SENSODYNESensitivity and Gum Whitening65.2 g in 1 TUBEPASTE65.26
0135-5024-02SENSODYNESensitivity and Gum Whitening1 in 1 CARTONPASTE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5024SENSODYNE SENSITIVITY AND GUM MINT (STANNOUS FLUORIDE) PASTE SENSODYNE SENSITIVITY AND GUM WHITENING (STANNOUS FLUORIDE) PASTE SENSODYNE SENSITIVITY AND GUM CLEAN AND FRESH (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 4 package rows20240308_ed093acd-255c-40ff-a010-d276f5844453.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNed093acd-255c-40ff-a010-d276f58444536
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDed093acd-255c-40ff-a010-d276f58444536
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYed093acd-255c-40ff-a010-d276f58444536
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYed093acd-255c-40ff-a010-d276f58444536
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYed093acd-255c-40ff-a010-d276f58444536

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-5024-01001355024011 TUBE in 1 CARTON (0135-5024-01) / 96.4 g in 1 TUBE1 tube2020-01-060000-00-00NoNoCurrent
0135-5024-02001355024021 TUBE in 1 CARTON (0135-5024-02) / 65.2 g in 1 TUBE1 tube2020-01-060000-00-00NoNoCurrent