Home Care Fluoride
- Product NDC
- 55346-0408
- 11-digit product format
- 553460408
- Labeler code
- 55346
- Product ID
- 55346-0408_42c872dd-4a65-b88b-e063-6394a90aab20
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Stannous Fluoride
- Dosage form
- GEL
- Route
- DENTAL; ORAL
- Labeler
- Dental Technologies, Inc.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1999-12-31
- Substance
- STANNOUS FLUORIDE
- Active strength
- .969 mg/g
- 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
- Home Care Fluoride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| STANNOUS FLUORIDE | .969 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3FTR44B32Q | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c44686f8-93ee-4a8f-8481-3439d123f6d2 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55346-0408-1 | Home Care Fluoride | 121.9 g in 1 TUBE | GEL | 121.9 | 11 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Stannous Fluoride | ACTIVE INGREDIENT | 3FTR44B32Q | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 5 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 5 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 5 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 5 | |
| CARBOMER 934P | INACTIVE INGREDIENT | Z135WT9208 | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 5 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 5 | |
| Trolamine | INACTIVE INGREDIENT | 9O3K93S3TK | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55346-0408 | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 10 | Current NDC, Legacy NDC, 1 package rows | 20240207_c44686f8-93ee-4a8f-8481-3439d123f6d2.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 Breath Purify and Gum Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c60fdacf-d997-19a5-e053-2a95a90a96a3 | 2026-01-08 | Warnings | M021 |
| Crest Cavity Protection Cool Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 3d7fffb9-47e0-73cd-e054-00144ff88e88 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Gum Detoxify Ultra | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c73ed36a-0e2f-a137-e053-2a95a90a43e0 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced Extra Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c688d37e-9e80-4599-e053-2a95a90a1916 | 2026-01-08 | Warnings | M021 |
| Crest Gum Detoxify plus Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 63779942-0f6c-11c5-e053-2991aa0a25ab | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Sensitivity Active Foam | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | b8535d1c-cf15-f353-e053-2a95a90a7974 | 2026-01-08 | Warnings | M021 |
| Burts Bees Extra White Zen Peppermint | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | 81279e1f-6224-8114-e053-2991aa0aab08 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Bacteria Shield and Gum Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c74229c4-b095-df32-e053-2a95a90a4aec | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Advanced Whitening Fresh Mint | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | c8350ab3-9347-58c0-e053-2995a90a7238 | 2026-01-08 | M021 | |
| Crest Premium Plus Anti-Bacterial | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | b7af946e-1cac-b8c0-e053-2a95a90afa4a | 2026-01-08 | Warnings | M021 |
| Crest 3D White Stain Eraser Polishing Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | ddcb0871-9900-125f-e053-2a95a90a75de | 2026-01-08 | M021 | |
| Burts Bees Deep Clean plus Whitening | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | c924b8dd-8d84-1329-e053-2995a90a4531 | 2026-01-08 | Warnings | M021 |
| Crest Plus Baking Soda and Peroxide Whitening with Tartar Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 07ed767e-225c-e9c5-e063-6394a90af931 | 2026-01-08 | Warnings | M021 |
| Crest Plus Cavity Protection Cool Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 0813171e-bda5-b004-e063-6394a90ad364 | 2026-01-08 | Warnings | M021 |
| Burts Bees Kids Strawberry Splash | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | 087b3434-2636-74ce-e063-6394a90a25ad | 2026-01-08 | Warnings | M021 |
| Crest plus Tartar Protection Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 08776dfc-b07a-3729-e063-6394a90aeeed | 2026-01-08 | Warnings | M021 |
| Crest Plus Active Fresh plus Whitening Scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 17f3b749-01ea-2561-e063-6294a90a5d3b | 2026-01-08 | Warnings | M021 |
| Crest 3D White Advanced Deep Clean | SODIUM FLUORIDE | Procter & Gamble Manfuacturing Company | 128613c4-c06b-bdf5-e063-6294a90acd34 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Pro Rinse | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 13a01190-a6f3-17b3-e063-6294a90a36c2 | 2026-01-08 | Warnings | M021 |
| HEB HEBuddy | FLUORIDE | HEB | 2c972c65-34aa-4348-b997-c5e65a884575 | 2026-01-08 | Warnings | M021 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55346-0408-1 | 55346040801 | 121.9 g in 1 TUBE (55346-0408-1) | 121.9 g | 1999-12-31 | 0000-00-00 | No | No | Current |