Home NDC 87548-020 Osstem G Gum Health Care Tooth
Product NDC 87548-020
11-digit product format 875480020
Labeler code 87548
Product ID 87548-020_4f8b4fc0-4c99-5e52-e063-6394a90af710
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route ORAL
Labeler Osstem Pharma Co., Ltd
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-01
Substance SODIUM FLUORIDE
Active strength .22 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 G Gum Health Care Tooth
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .22 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 245598 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 87548-020-01 Osstem G Gum Health Care Tooth 120 g in 1 TUBE PASTE, DENTIFRICE 120 1 87548-020-02 Osstem G Gum Health Care 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 6 of 50 · 995 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 87548-020-01 87548002001 120 g in 1 TUBE 120 g Historical 87548-020-02 87548002002 1 TUBE in 1 CARTON (87548-020-02) / 120 g in 1 TUBE (87548-020-01) 1 tube 2026-04-01 No No Current