NDC 55346-0401-01 - Home Care Fluoride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 55346-0401
- Requested NDC
- 55346-0401-01
- Package NDCs from labels
- 55346-0401-1, 55346-0401-01
- Manufacturer
- Dental Technologies, Inc.
- Effective date
- 2025-11-04
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| DTI Stannous - Mint | Dental Technologies, Inc. | 2025-11-04 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55346-0401-1 | Home Care Fluoride | 121.9 g in 1 TUBE | GEL | 121.9 | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55346-0401 | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20240207_15bdc03e-2cc7-4b7d-96fc-4f3236ed5c75.zip |
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.] | 4 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| CARBOMER 934P | INACTIVE INGREDIENT | Z135WT9208 | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| Trolamine | INACTIVE INGREDIENT | 9O3K93S3TK | HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 |
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 |
|---|---|---|---|---|---|---|
| Sensitive Teeth and Gums | POTASSIUM NITRATE, SODIUM FLUORIDE | Church & Dwight Co., Inc. | 935172db-d78f-0c69-e053-2a95a90a0b69 | 2026-07-23 | Warnings | M021 |
| Essentials Whiten and Strengthen | SODIUM FLUORIDE 0.24% | Church & Dwight Co., Inc. | 96548550-2cd1-b757-e053-2995a90a15ea | 2026-07-23 | Warnings | M021 |
| TP COL OW Purple | SODIUM FLUORIDE | Colgate-Palmolive Company | ea0db59f-f9c0-49a8-9717-69cdf071f6e1 | 2026-07-23 | Warnings | M021 |
| Colgate Max Fresh Cool Mint | SODIUM FLUORIDE | Colgate-Palmolive Company | 00652bb2-090c-4eaa-8fc2-e0be6913a724 | 2026-07-22 | Warnings | M021 |
| Droptics Dry Eye Relief | CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80 | Droptics LLC | 29d7614b-f4b7-48e2-97c5-d1bff27731d2 | 2026-07-22 | Warnings | PDC6A3C0OX |
| PNV-Omega | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENT | Acella Pharmaceuticals, LLC | 735c5531-137f-4cee-8c68-ae121045a8ff | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | PQ6CK8PD0R |
| Xenleta | LEFAMULIN ACETATE | Meitheal Pharmaceuticals Inc. | eb972ea8-7502-422e-84bb-66cb8e93ca06 | 2026-07-22 | Warnings, Adverse reactions | XF417D3PSL |
| Colgate Ultra White Charcoal | SODIUM FLUORIDE | Colgate-Palmolive Company | 95d06fcc-f56d-43f1-924a-3f91fda59bdf | 2026-07-22 | Warnings | M021 |
| COLGATE Great Regular Flavor | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | 730f40f6-6ac6-49bd-888b-c0b5818a03c8 | 2026-07-20 | Warnings | M021 |
| COLGATE KPOP DEMON HUNTERS BUBBLE POP | SODIUM FLUORIDE | Colgate-Palmolive Company | bf465181-01e9-44ca-91f8-03110a606774 | 2026-07-16 | Warnings | M021 |
| Colgate Minions Mild Bubble Fruit Fluoride | SODIUM FLUORIDE | Colgate-Palmolive Company | 16634b99-f305-48bf-ac54-a9f53797a9e5 | 2026-07-16 | Warnings | M021 |
| Freshen Up Holiday mint | SODIUM FLUORIDE | Dabur India Limited | 56aaa9f5-7eac-11d9-e063-6294a90af3a8 | 2026-07-15 | Warnings | M021 |
| Freshen Up pepper mint | SODIUM FLUORIDE | Dabur India Limited | 56aaba60-523e-6ac7-e063-6394a90a2756 | 2026-07-15 | Warnings | M021 |
| Freshen-up Matcha Mint | SODIUM FLUORIDE | Dabur India Limited | 56aac050-73e7-298c-e063-6294a90a26eb | 2026-07-15 | Warnings | M021 |
| Freshen Up twisted peppermint | SODIUM FLUORIDE | Dabur India Limited | 56aac7a7-c086-2fa5-e063-6294a90aa959 | 2026-07-15 | Warnings | M021 |
| Freshen Up Vanilla Mint | SODIUM FLUORIDE | Dabur India Limited | 56aad223-db88-7cf6-e063-6394a90a6b72 | 2026-07-15 | Warnings | M021 |
| Freshen Up | SODIUM FLUORIDE | MKJ BRANDS LLC | 2dcd4816-caa5-c006-e063-6394a90ac487 | 2026-07-15 | Warnings | M021 |
| Freshen Up | SODIUM FLUORIDE | DABUR INDIA LIMITED | 56acecd2-6966-2ee4-e063-6394a90a356f | 2026-07-15 | Warnings | M021 |
| Colgate Max Fresh Advanced Whitening | SODIUM FLUORIDE | Colgate-Palmolive Company | 01c07c25-2748-4d90-9505-094e2c977c9c | 2026-07-15 | Warnings | M021 |
| Crest Strawberry | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 7d51c67b-7409-e5a7-e053-2a91aa0a81fa | 2026-07-14 | Warnings | M021 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.