Osstem S Sensitivity relief tooth
- Product NDC
- 87548-010
- 11-digit product format
- 875480010
- Labeler code
- 87548
- Product ID
- 87548-010_5ebaa015-8dbf-7aec-e063-6294a90affc2
- 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 |
|---|---|
| SODIUM FLUORIDE | .221 g/100g |
| POTASSIUM NITRATE | 5 g/100g |
DailyMed Package Descriptions#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Topcare Maximum Strength | BENZOCAINE | Topco Associates LLC | 6586fcda-b232-46b4-8461-c0042a4127c6 | 2026-10-06 | Warnings | M022 |
| CrystLCare Regeneration Plus | POTASSIUM NITRATE, SODIUM FLUORIDE | GreenMark Biomedical Inc. | 4f86d0a0-d73e-5605-e063-6394a90adb38 | 2026-09-14 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | 9a9c5c6b-94fe-484a-a879-12c29cbdefe4 | 2026-09-11 | Warnings | M022 |
| Opalescence Whitening Sensitivity Relief | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | 44e94663-895b-67da-e063-6394a90a5fe6 | 2026-09-09 | Warnings | M022 |
| Opalescence Sensitivity Relief Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | b5176a84-76a3-4ad0-a2e2-4997a12da9a5 | 2026-09-09 | Warnings | M022 |
| Opal by Opalescence Sensitivity | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | 5ffc0d14-0290-47bb-90e5-90a25a5acc28 | 2026-09-09 | Warnings | M022 |
| Saline | NASAL | Raritan Pharmaceuiticals Inc | 4b178e4e-a10f-4b75-8140-1f7548e203ad | 2026-09-09 | Warnings | M022 |
| SORE THROAT | PHENOL | Raritan Pharmaceuticals Inc | 43ce374a-824c-4034-bf04-c351b4d8015b | 2026-09-08 | Warnings | M022 |
| Colgate Optic White Stain Fighter Sens Relief | SODIUM FLUORIDE | Colgate-Palmolive Company | 6ec2fff7-df44-4302-be2d-97946c6cd66a | 2026-09-08 | Warnings | M022 |
| DRx Choice Sore Throat Menthol Flavor | PHENOL | RARITAN PHARMACEUTICALS INC | e3269b12-5c05-45a6-81f2-65d9f016c3aa | 2026-09-08 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 0733015b-e81a-4a62-82ad-dacaf3f163cb | 2026-09-02 | Warnings | M022 |
| KROGER Saline | NASAL | KROGER COMPANY | c84b242b-f46e-4ea8-a3c1-109a47644646 | 2026-09-02 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | ceb125d9-8c1b-498c-b0f0-f18756ede442 | 2026-09-01 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1c82b4-02b3-d456-e063-6294a90a16bb | 2026-08-31 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum PM Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1cdaf4-3388-280c-e063-6294a90ac70f | 2026-08-31 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT | HEXYLRESORCINOL | Reckitt Benckiser LLC | 91cd2964-5d83-4e40-bc18-e3e5462f454a | 2026-08-31 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF | HEXYLRESORCINOL | Reckitt Benckiser LLC | 4c150222-06ea-4fcf-967f-84e19846bd66 | 2026-08-31 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1b4133-0eac-2f8f-e063-6394a90af8f6 | 2026-08-28 | Warnings | M022 |
| LUDENS SUGAR FREE WILD CHERRY THROAT | PECTIN | Prestige Brands Holdings, Inc. | 274fc80c-e5b2-41c7-a119-287d6e8a2258 | 2026-08-28 | Warnings | M022 |
| Medline Peroxi Fresh Mouthwash | HYDROGEN PEROXIDE | Medline Industries, LP | ec7a9240-6c66-4471-b8b6-776e08a14fbc | 2026-08-27 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2741131 | potassium nitrate 5 % / sodium fluoride 0.221 % (fluoride ion 0.10 % ) Toothpaste | PSN | 4f8ab179-8f29-a7cf-e063-6294a90a0c22 | 1 |
| 2741131 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.00221 MG/MG Toothpaste | SCD | 4f8ab179-8f29-a7cf-e063-6294a90a0c22 | 1 |
| 2741131 | K+ nitrate 0.05 MG/MG / sodium fluoride 0.00221 MG/MG Toothpaste | SY | 4f8ab179-8f29-a7cf-e063-6294a90a0c22 | 1 |
| 2741131 | Pot nitrate 0.05 MG/MG / sodium fluoride 0.00221 MG/MG Toothpaste | SY | 4f8ab179-8f29-a7cf-e063-6294a90a0c22 | 1 |
| 2741131 | potassium nitrate 5 % / sodium fluoride 0.221 % (fluoride ion 0.10 % ) Toothpaste | SY | 4f8ab179-8f29-a7cf-e063-6294a90a0c22 | 1 |
Packages#
| 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 |