Osstem S Sensitivity relief tooth

Product NDC
87548-010
11-digit product format
875480010
Labeler code
87548
Product ID
87548-010_4f8ab179-8f2a-a7cf-e063-6294a90a0c22
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Nitrate, Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Osstem Pharma Co., Ltd
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-01
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .221 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Osstem S Sensitivity relief tooth
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE.221 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui2741131

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87548-010-01Osstem S Sensitivity relief tooth120 g in 1 TUBEPASTE, DENTIFRICE1201
87548-010-02Osstem S Sensitivity relief tooth1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2741131potassium nitrate 5 % / sodium fluoride 0.221 % (fluoride ion 0.10 % ) ToothpastePSN4f8ab179-8f29-a7cf-e063-6294a90a0c221
2741131potassium nitrate 0.05 MG/MG / sodium fluoride 0.00221 MG/MG ToothpasteSCD4f8ab179-8f29-a7cf-e063-6294a90a0c221
2741131K+ nitrate 0.05 MG/MG / sodium fluoride 0.00221 MG/MG ToothpasteSY4f8ab179-8f29-a7cf-e063-6294a90a0c221
2741131Pot nitrate 0.05 MG/MG / sodium fluoride 0.00221 MG/MG ToothpasteSY4f8ab179-8f29-a7cf-e063-6294a90a0c221
2741131potassium nitrate 5 % / sodium fluoride 0.221 % (fluoride ion 0.10 % ) ToothpasteSY4f8ab179-8f29-a7cf-e063-6294a90a0c221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87548-010-0187548001001120 g in 1 TUBE120 gHistorical
87548-010-02875480010021 TUBE in 1 CARTON (87548-010-02) / 120 g in 1 TUBE (87548-010-01) 1 tube2026-04-01NoNoCurrent