Home NDC 87548-010 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 SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength .221; 5 g/100g; g/100g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Osstem S Sensitivity relief tooth
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .221 g/100g POTASSIUM NITRATE 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2741131 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 87548-010-01 Osstem S Sensitivity relief tooth 120 g in 1 TUBE PASTE, DENTIFRICE 120 1 87548-010-02 Osstem S Sensitivity relief tooth 1 in 1 CARTON PASTE, DENTIFRICE 1 1
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 28 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87548-010-01 87548001001 120 g in 1 TUBE 120 g Historical 87548-010-02 87548001002 1 TUBE in 1 CARTON (87548-010-02) / 120 g in 1 TUBE (87548-010-01) 1 tube 2026-04-01 No No Current