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 |
|---|---|---|---|---|---|---|
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Family Dollar Stores, Inc | 32ebc633-5338-4d5a-b075-f10b24761248 | 2026-02-24 | Warnings, Adverse reactions | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | H E B | 51ddc81b-1c90-4998-b538-6761ac113437 | 2026-02-24 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Meijer, Inc. | 9a0b6301-2443-41f7-adeb-87578a65c26d | 2026-02-24 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | CVS Pharmacy, Inc. | 344c9d00-ad82-46a9-83e9-68197e1a68bb | 2026-02-23 | Warnings, Adverse reactions | M021 |
| TheraBreath Complete Oral Rinse | ANTICAVITY ORAL RINSE | Church & Dwight Co., Inc. | 27c33ae1-52c7-baad-e063-6394a90a0611 | 2026-02-23 | Warnings | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Meijer, Inc. | 001777fb-196c-499a-94c8-6cdcef0958e9 | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Meijer, Inc. | c628d02f-c834-42b3-b38d-6b9cdcdd0961 | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Meijer, Inc. | b17f7a5d-272e-446d-803b-46a6d8e5f18f | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Meijer, Inc. | d85ce60c-ebff-461f-827a-10fddb9c2bf3 | 2026-02-19 | Warnings, Adverse reactions | M021 |
| White Glo Charcoal Baking Soda Maximum White Fluoride Anticavity | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | 580c4622-6f9c-48ea-b01e-6ffba7273f24 | 2026-02-19 | Warnings | M021 |
| White Glo Coffee and Tea Stain Remover Fluoride Anticavity | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | f044e213-2403-4f42-a41d-72d58fefcfcb | 2026-02-19 | Warnings | M021 |
| White Glo Mouthwash Protect Fluoride Anticavity | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | 4691584f-8c0c-4589-8b40-89b1779a438d | 2026-02-19 | Warnings | M021 |
| White Glo Professional Choice Fluoride Anticavity | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | ed8d7506-0385-4422-be77-bcc2db79882f | 2026-02-19 | Warnings | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Meijer, Inc. | c4dcb1d8-f2af-4363-8fcd-c7d1197d66ea | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Oral Antivavity | SODIUM FLUORIDE | Meijer, Inc. | af34f83f-1328-4897-9d04-72ca5a4101bf | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Meijer, Inc. | acff939e-e98c-4d89-a0c4-0254dc74e672 | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Anticavity fluoride rinse | SODIUM FLUORIDE | Meijer, Inc. | 0bb9fb5f-1893-4187-b60b-05319a8fac6a | 2026-02-19 | Warnings, Adverse reactions | M021 |
| Listerine Total Care Intense Anticavity Fluoride Mouthwash | SODIUM FLUORIDE | Kenvue Brands LLC | 4b0404af-309f-7c31-e063-6294a90a5aa1 | 2026-02-18 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Target Corporation | abfc1973-60ab-44e5-8147-33739d8bd7a3 | 2026-02-18 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Target Corporation | 3e4119b2-9506-4305-8cff-163f700265d0 | 2026-02-18 | 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 |