SENSODYNE

Product NDC
0135-5022
11-digit product format
001355022
Labeler code
0135
Product ID
0135-5022_13128d65-3388-ef9b-e063-6394a90af6ff
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
2023-01-02
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 Gum and Enamel Mint
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
0135-5022-01SENSODYNESensitivity Gum and Enamel Mint1 in 1 CARTONPASTE14
0135-5022-01SENSODYNESensitivity Gum and Enamel Mint96.4 g in 1 TUBEPASTE96.44
0135-5022-02SENSODYNESensitivity Gum and Enamel Mint65.2 g in 1 TUBEPASTE65.24
0135-5022-02SENSODYNESensitivity Gum and Enamel Mint1 in 1 CARTONPASTE14
0135-5022-03SENSODYNESensitivity Gum and Enamel Mint2 in 1 CARTONPASTE24
0135-5022-03SENSODYNESensitivity Gum and Enamel Mint96.4 g in 1 TUBEPASTE96.44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5022SENSODYNE SENSITIVITY GUM AND ENAMEL MINT (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 6 package rows20240308_d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e24
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e24
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e24
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e24
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-5022-01001355022011 TUBE in 1 CARTON (0135-5022-01) / 96.4 g in 1 TUBE1 tube2023-01-020000-00-00NoNoCurrent
0135-5022-02001355022021 TUBE in 1 CARTON (0135-5022-02) / 65.2 g in 1 TUBE1 tube2023-01-020000-00-00NoNoCurrent
0135-5022-03001355022032 TUBE in 1 CARTON (0135-5022-03) / 96.4 g in 1 TUBE2 tube2024-01-02NoNoHistorical