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 |
|---|---|---|---|---|---|---|
| Toms of Maine Whiten Plus Deep Clean Peppermint | SODIUM FLUORIDE | Tom's of Maine | 4c535776-3f80-4eeb-bb63-2d734c3c3a6b | 2026-02-18 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | United Natural Foods, Inc. dba UNFI | dd6bf8df-1e28-4f61-b876-b9f1f8d5993a | 2026-02-17 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | United Natural Foods, Inc. dba UNFI | 8283cea0-7b62-4796-8763-6654039664cd | 2026-02-17 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | United Natural Foods, Inc. dba UNFI | 9d055fed-26d8-4827-a4cc-8c314514a6c3 | 2026-02-17 | Warnings | M021 |
| Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVOR | SODIUM FLUORIDE | Ashtel Studios, Inc. | 28d1b8c3-930f-4ac9-aa5a-b72b832bb77e | 2026-02-17 | Warnings | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Valu Merchandisers Company | 088b95e6-30fd-4263-9fdc-57cd63385b71 | 2026-02-16 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Valu Merchandisers Company | e31c1609-a1c3-4ed5-adfd-3cfa63205ec3 | 2026-02-16 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | United Natural Foods, Inc. dba UNFI | 3602c528-5f53-4d41-bf67-163149f52b35 | 2026-02-16 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | United Natural Foods, Inc. dba UNFI | e696038c-182e-4325-9b90-87fe498d9f67 | 2026-02-16 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Topco Associates LLC | 3b04142a-4a65-45ba-a5a2-e62b0c47ec55 | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Mouth Rinse | SODIUM FLUORIDE | Topco Associates LLC | c640adc0-e178-4b6a-af44-07d2f7da81d3 | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Topco Associates LLC | f760f8f8-0c74-4a6e-b5c9-cc82b8758a45 | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Topco Associates LLC | ade7dcb2-b4e2-4cef-b9a7-469867ead68a | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Oral Antivavity | SODIUM FLUORIDE | Topco Associates LLC | 84b30711-a7e5-4189-895a-a7989f05591c | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Anticavity fluoride rinse | SODIUM FLUORIDE | Topco Associates LLC | c3f2e952-a8d5-4e9d-a5c6-09e4f2544179 | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Topco Associates LLC | a9b8b2fe-0a60-4f65-b6f6-aae8509c919f | 2026-02-13 | Warnings, Adverse reactions | M021 |
| Salivea | FLUORIDE TOOTHPASTE | Laclede, Inc. | 4abb0f80-d87d-730f-e063-6294a90a15f7 | 2026-02-13 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Your Military Exchanges | 581d5cdb-018a-42ad-899d-5331f0063376 | 2026-02-12 | Warnings, Adverse reactions | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Your Military Exchanges | 965911c3-7aa8-4830-8269-6aa5d526ee73 | 2026-02-12 | Warnings, Adverse reactions | M021 |
| Mouth Rinse | SODIUM FLUORIDE | Walgreen Co. | eae87899-3eba-4d50-bc31-9eaf54ff9e00 | 2026-02-12 | Warnings, Adverse reactions | 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 |