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 Sensitive and Enamel Shield | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb48b15c-f821-e5cd-e053-6294a90ac64c | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Luminous Purple | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | fbfcd837-4d88-5f82-e053-6394a90afbf6 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health with a Touch of Scope | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb572b41-36cd-55d7-e053-6394a90a71c8 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Whitening Gel | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb5b1e94-bed6-8486-e053-6294a90a3a84 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Ultra Vivid Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | cba96ef0-0519-059f-e053-2a95a90a43ad | 2026-01-08 | Warnings | M021 |
| Crest 4in1 | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | ce545406-3c4f-1ba7-e053-2a95a90a91ac | 2026-01-08 | Warnings | M021 |
| Crest 3D White Advanced Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d218ddc0-1d5f-f39b-e053-2995a90a96ed | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Antibacterial Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d58bc842-2687-e52d-e053-2995a90a5433 | 2026-01-08 | Warnings | M021 |
| Scope Stay Strong | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d65b3153-2026-a8c0-e053-2a95a90a31d6 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Whitening Charcoal | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d6f68485-b92f-41c7-e053-2995a90a4fe5 | 2026-01-08 | Warnings | M021 |
| KIDS Crest Advanced Enamel Plus Cavity Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d837ecde-249a-7868-e053-2a95a90a56ae | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Whitening Intensive Cleaning | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d6fa4187-a651-647b-e053-2995a90a8567 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Gum Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d7729dde-c828-34e6-e053-2a95a90a5ee6 | 2026-01-08 | Warnings | M021 |
| Crest Densify Daily Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d811306f-4994-7a5a-e053-2995a90adf16 | 2026-01-08 | Warnings | M021 |
| Crest Densify Daily Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d810d4e5-ba66-efe1-e053-2995a90abfc0 | 2026-01-08 | Warnings | M021 |
| Crest Braces Care Cavity Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d823cba4-c4cf-7d7a-e053-2995a90a01f0 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Sensitive Relief | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d7730674-7513-52cf-e053-2995a90ab32c | 2026-01-08 | Warnings | M021 |
| Kids Crest Bubblegum Flavor | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 26a7a892-5da4-4749-bbb6-566efab7d749 | 2026-01-08 | Warnings | M021 |
| Crest Complete Multi-Benefit Plus Scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 8c91095d-88c0-4d22-a79a-7d0f0d05302b | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Deep Clean Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d774295f-8ebd-9877-e053-2a95a90a9a0e | 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 |