Gelato Homecare
- Product NDC
- 68400-201
- 11-digit product format
- 684000201
- Labeler code
- 68400
- Product ID
- 68400-201_1679a47c-dc75-72ca-e063-6294a90a39c0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Stannous Fluoride
- Dosage form
- GEL
- Route
- DENTAL
- Labeler
- Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-01-05
- Substance
- STANNOUS FLUORIDE
- Active strength
- .116 g/120g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- Gelato Homecare
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| STANNOUS FLUORIDE | .116 g/120g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3FTR44B32Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 237847 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68400-201-04 | Gelato Homecare | 120 g in 1 TUBE | GEL | 120 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68400-201 | GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240426_1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db.zip |
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 |
|---|---|---|---|---|---|---|
| Colgate Total SF Whitening | STANNOUS FLUORIDE | Colgate-Palmolive Company | 3bba340e-2a62-3b04-41b5-0ed9c13adb13 | 2026-04-22 | Warnings | M021 |
| EverSmile Squirt | SODIUM FLUORIDE 0.05% | Everbrands, Inc. | bc0ef174-2909-469a-b629-0eab4412bdfc | 2026-04-20 | Warnings | M021 |
| Gum Detoxify | STANNOUS FLUORIDE | Walmart | 41d6cc7a-0b87-e474-e063-6294a90ae995 | 2026-04-20 | Warnings | M021 |
| Eversmile Squirt | 2.65% HYDROGEN PEROXIDE | Everbrands, Inc. | 2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf | 2026-04-19 | Warnings | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | H E B | 8d40f693-083c-4eb6-9da1-42675d757e0e | 2026-04-16 | Warnings, Adverse reactions | M021 |
| Eversmile OrthoFoam Anticavity | 0.05% SODIUM FLUORIDE RINSE | Everbrands, Inc. | 9c12e792-94c8-4e29-9a54-e7e70aadade6 | 2026-04-16 | Warnings | M021 |
| Eversmile Squirt | 2.65% HYDROGEN PEROXIDE | Everbrands, Inc. | 6753b426-6d49-4438-a52f-c28e60a0e9d8 | 2026-04-16 | Warnings | M021 |
| Osstem G Gum Health Care Tooth | SODIUM FLUORIDE | Osstem Pharma Co., Ltd | 4f8b4fc0-4c98-5e52-e063-6394a90af710 | 2026-04-15 | Warnings | M021 |
| Crest 3D White Deep Stain Remover Enamel Strength | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | 4f6b8851-c778-8abd-e063-6294a90aef4f | 2026-04-14 | M021 | |
| Crest 3D White Stain Eraser Luxe Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f6beb3b-2521-bfb7-e063-6394a90ad9ea | 2026-04-14 | M021 | |
| Kids Crest Strawberry Rush | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d13 | 2026-04-14 | Warnings | M021 |
| Crest Pro-Health Mouthwash Multi-Protection Strong Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f6d11b2-5aa2-ab34-e063-6294a90ac0bc | 2026-04-14 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Publix Super Markets, Inc. | cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb | 2026-04-14 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Publix Super Markets, Inc. | f0e84078-499f-4a5a-bcd2-23f57805de86 | 2026-04-14 | Warnings, Adverse reactions | M021 |
| Crest Pro-Health Advanced Multi-Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 1cfc5b61-c8e5-943d-e063-6394a90a890b | 2026-04-14 | Warnings | M021 |
| Crest Pro-Health Multi-Protection plus Extra Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f6f6299-f95f-2f0e-e063-6294a90a1641 | 2026-04-14 | Warnings | M021 |
| Crest 3D White Strength Whitening Enamel Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f7125aa-3aa2-ca64-e063-6394a90a4cf3 | 2026-04-14 | Warnings | M021 |
| Eversmile TheraFoam | 0.05% SODIUM FLUORIDE RINSE | Everbrands, Inc. | 57da2479-923a-45ec-8149-57b469b11637 | 2026-04-13 | Warnings | M021 |
| Crest Pro-Health Advanced Bacteria Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f1ce508-fe6e-4045-e063-6294a90ab3e2 | 2026-04-10 | Warnings | M021 |
| Crest Pro-Health Sensitivity Relief | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | 4f1d62ae-653e-3046-e063-6294a90abbf8 | 2026-04-10 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 237847 | stannous fluoride 0.4 % Oral Gel | PSN | 1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db | 7 |
| 237847 | stannous fluoride 0.004 MG/MG Oral Gel | SCD | 1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db | 7 |
| 237847 | stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel | SY | 1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68400-201-04 | 68400020104 | 120 g in 1 TUBE (68400-201-04) | 120 g | 2016-09-01 | 0000-00-00 | No | No | Current |