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 |
|---|---|---|---|---|---|---|
| Crest Pro-Health Gum Detoxify Plus | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 2f9e346e-d664-81d5-e063-6394a90a4525 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Holiday Smile Deep Stain Remover and Whitestrips | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | 3c57d487-a3c7-b238-e063-6294a90aed81 | 2026-01-08 | M021 | |
| Crest Complete plus Scope Pro Advanced Freshness | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 325c3ab2-aaa2-a06f-e063-6294a90abefb | 2026-01-08 | Warnings | M021 |
| Crest Tartar Protection | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 5940711d-71b7-cb7d-e053-2a91aa0aef18 | 2026-01-08 | Warnings | M021 |
| Meijer Restore and Defend Sensitive | STANNOUS FLUORIDE | Meijer Distribution Inc | 82bdfdb5-39f2-8c09-e053-2991aa0a096c | 2026-01-08 | Warnings | M021 |
| Crest Strawberry | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 01f69824-e886-6e7b-e063-6294a90acf77 | 2026-01-08 | Warnings | M021 |
| Crest Bubblegum | SODIUM FLUORIDE | Procter & Gamble Manufacturing Mxico, S. de R.L. de C.V. | 01f64874-6363-3dcc-e063-6394a90a2aec | 2026-01-08 | Warnings | M021 |
| Crest 3D White Fresh Mint | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 01f27a63-15f3-cee4-e063-6394a90afa3b | 2026-01-08 | Warnings | M021 |
| Crest Bubblegum | SODIUM FLUORIDE | Procter & Gamble Manufacturing Mxico, S. de R.L. de C.V. | 01f618d7-be07-18c3-e063-6294a90a2d97 | 2026-01-08 | Warnings | M021 |
| Crest Strawberry | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 01f35279-76ce-6027-e063-6294a90a8e34 | 2026-01-08 | Warnings | M021 |
| Crest Snowberry | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 42ca1f06-3e7d-8fed-e063-6394a90afbff | 2026-01-08 | Warnings | M021 |
| Crest Strawberry | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 7d615c52-f9c9-4856-e053-2991aa0a7927 | 2026-01-08 | Warnings | M021 |
| Crest Fresh and White | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 5a1bb1fb-12a5-5fd1-e053-2991aa0a628b | 2026-01-08 | Warnings | M021 |
| Crest 3D White Stain Eraser Icy Clean Mint | SODIUM FLUORIDE | Procter & Gamble Manufacturing Mxico, S. de R.L. de C.V. | 8de12c9f-eb16-aa26-e053-2a95a90a1b9c | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Peppermint Frost | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 42c84772-d406-b6ca-e063-6394a90a920f | 2026-01-08 | Warnings | M021 |
| Crest 3D White Sparkle Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 42cb1b2a-55ad-cb9c-e063-6294a90ac88c | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Gum Recession | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 47be4eff-1ab5-17a1-e063-6394a90ae465 | 2026-01-08 | Warnings | M021 |
| Supersmile Professional Whitening TP | SODIUM MONOFLUOROPHOSPHATE | Robell Research, Inc | 25021787-44e8-0b29-e063-6394a90a0af6 | 2026-01-08 | Warnings | M021 |
| Supersmile Professional whitening TP Original Mint | SODIUM MONOFLUOROPHOSPHATE | Robell Research, Inc | 2502c305-71ab-bb71-e063-6394a90a0a84 | 2026-01-08 | Warnings | M021 |
| Supersmile Professional Whitening TP Original Mint | SODIUM MONOFLUOROPHOSPHATE | Robell Research, Inc | 2502840c-82ee-12cb-e063-6394a90a5b3f | 2026-01-08 | 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 |