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 |
|---|---|---|---|---|---|---|
| Dentalclean Blue Diamond Alcohol Free Mouthwash | SODIUM FLUORIDE 0.05% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 1881658c-e371-5513-e063-6394a90a465f | 2024-05-15 | Warnings | M021 |
| Dentalclean Dr. Duck Strawberry flouride Mouthwash | SODIUM FLUORIDE 0.02% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 1882c82a-3a32-5656-e063-6394a90ae0ed | 2024-05-15 | Warnings | M021 |
| Dentalclean Booster Kids | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 186ecaeb-9401-9315-e063-6394a90a8e20 | 2024-05-14 | Warnings | M021 |
| BIO SPECTRA ATTITUDE | SODIUM FLUORIDE | 9055-7588 Qubec Inc. DBA ATTITUDE | fefc1060-e1a4-4686-a8d8-84bf1e613abe | 2024-05-14 | Warnings | M021 |
| Dentalclean Doctor Duck | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 186f2f12-279f-32df-e063-6394a90ad53d | 2024-05-14 | Warnings | M021 |
| Barbie Bubble Gum ANTICAVITY FLUORIDE | SODIUM FLUORIDE | Ashtel Studios Inc. | dc5489e9-eeff-4db5-8793-21fb5bf4b2ef | 2024-05-10 | Warnings | M021 |
| Dentalclean Regenerator Sensitive Kids | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 17f31b5e-dd3b-78df-e063-6294a90a43ab | 2024-05-08 | Warnings | M021 |
| Dentalclean Dental Gel Booster Adult Use | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 17f3981f-ab4b-0dcd-e063-6294a90a37d9 | 2024-05-08 | Warnings | M021 |
| Dentalclean Sensitive Plus | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 17e0dc93-97bf-7f05-e063-6294a90a9a8b | 2024-05-07 | Warnings | M021 |
| Dentalclean Whitening Max | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 17e2364e-2511-3021-e063-6294a90a40e1 | 2024-05-07 | Warnings | M021 |
| DeCure | SODIUM MONOFLUOROPHOSPHATE | Scope medical devices private limited | 590c4827-f036-45bd-af30-0a4853ca3447 | 2024-05-07 | Warnings | M021 |
| Gelato Homecare | STANNOUS FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf | 2024-04-22 | Warnings | M021 |
| Gelato Homecare | STANNOUS FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db | 2024-04-19 | Warnings | M021 68400-201 |
| Toothpaste, plus Toothbrush | SODIUM FLUORIDE PASTE, DENTIFRICE AND TOOTHBRUSH | Lil' Drug Store Products, Inc. | 15ac00f8-da51-6cea-e063-6294a90aeb81 | 2024-04-09 | Warnings | M021 |
| HIMALAYA PINK SALT Intensive Whitening Spearmint | SODIUM FLUORIDE | LG H&H Co.,Ltd. | 14ea1776-ef7f-27a9-e063-6394a90afd49 | 2024-03-29 | Warnings | M021 |
| HIMALAYA PINK SALT Intensive Whitening Spearmint | SODIUM FLUORIDE | Tai Guk Pharma. Co., Ltd. | 14eb9f74-e5f5-e199-e063-6394a90adbf6 | 2024-03-29 | Warnings | M021 |
| Dentalclean Ultra Refreshing Extreme Ice Dental Gel | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 1496636d-6563-d474-e063-6394a90ab73d | 2024-03-26 | Warnings | M021 |
| Scope Stay Strong | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 142bffe1-1e8c-8567-e063-6394a90af15a | 2024-03-21 | Warnings | M021 |
| Made by Dentists Ultra Whitening Fresh Mint | SODIUM FLUORIDE | MADE BY DENTISTS INC | dbce2aba-48db-4e78-bf79-74f34868ee37 | 2024-03-15 | Warnings | M021 |
| EUTHYMOL Extraordinary Pink Whitening | SODIUM FLUORIDE | Tai Guk Pharm. Co., Ltd. | 13907bf6-9a95-c0b2-e063-6394a90a4042 | 2024-03-13 | 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 |