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 complete plus Whitening Deep Clean | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 973ce138-c64e-c059-e053-2a95a90a3148 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Gum Detoxify and Restore Pro Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | f4c3ad36-72d8-16e8-e053-2a95a90a8702 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Gum Detoxify and Restore Pro Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | f4d65b58-9818-820d-e053-2995a90a9f00 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Sensitive and Gum All Day Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | f4d775a1-a4f6-cd69-e053-2995a90a5f64 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Enamel Repair and Gum Advanced Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | f4ead762-17b2-22a0-e053-2a95a90ac866 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Advanced Luminous Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f5c82742-fb27-62a2-e053-2a95a90aa7c4 | 2026-01-08 | Warnings | M021 |
| Native Whitening | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | a5248d35-f488-3457-e053-2995a90a411e | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Charcoal | SODIUM FLUORIDE | Procter & Gamble Manfuacturing Company | b7882679-339c-554f-e053-2995a90afa7f | 2026-01-08 | Warnings | M021 |
| Burts Bees Kids Strawberry Splash | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | b6c180ae-00da-6fab-e053-2a95a90a089e | 2026-01-08 | Warnings | M021 |
| Crest Complete Plus Scope Outlast | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | b6f9a813-7ed6-895c-e053-2995a90a9ea6 | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Scope Dual Blast Active Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | b788d16a-8a58-0352-e053-2a95a90a965e | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Scope Outlast Active Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | b789587e-7f49-163a-e053-2a95a90a823f | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Advanced Whitening Active Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | b81a22dc-b759-24cd-e053-2995a90a9148 | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Deep Clean Active Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | b851fe5c-d904-12da-e053-2a95a90a86f9 | 2026-01-08 | Warnings | M021 |
| Crest Baking Soda and Peroxide Whitening with Tartar Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | adebbd47-011d-4cd3-a002-1eb67e885e5b | 2026-01-08 | Warnings | M021 |
| Crest 3D White Advanced Stain Shield | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f5c9b5ef-8dd4-a842-e053-2a95a90ad387 | 2026-01-08 | Warnings | M021 |
| Kids Crest Bubblegum Rush | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 7baa77f5-fe45-6566-e053-2991aa0a381f | 2026-01-08 | Warnings | M021 |
| Crest 3D White Vibrant Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f63c3354-a264-8130-e053-2a95a90a2022 | 2026-01-08 | M021 | |
| Crest Pro Health Clean Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb466fb4-0915-a41f-e053-6294a90a2dfb | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Clean and Free | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb4771cd-f478-e2bd-e053-6394a90aa83e | 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 |