COLGATE OPTIC WHITE RENEWAL REVITALIZING WHITE
- Product NDC
- 35000-340
- 11-digit product format
- 350000340
- Labeler code
- 35000
- Product ID
- 35000-340_0989bf02-0835-4bee-8197-213f65740a3d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- SODIUM MONOFLUOROPHOSPHATE
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Colgate-Palmolive Company
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-10-13
- Substance
- SODIUM MONOFLUOROPHOSPHATE
- Active strength
- 1 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- COLGATE OPTIC WHITE RENEWAL REVITALIZING WHITE
- Brand name suffix
- GLISTENING MINT
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM MONOFLUOROPHOSPHATE | 1 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| C810JCZ56Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 545626 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 00da2772-6f20-4444-8baf-b12953c9644a | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Tanners Tasty Cha Cha Chocolate | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | 8609dbf3-7620-4a13-b40b-6bd705a78fb0 | 2023-10-24 | Warnings | M021 |
| Glister Multi-Action | SODIUM FLUORIDE | Access Business Group LLC | e3f2c049-a0f5-4649-a4aa-11bdb252f951 | 2023-10-23 | Warnings | M021 |
| UNITED Asutra TC Kit Colgate | SODIUM MONOFLUOROPHOSPHATE | MING FAI ENTERPRISE (CAMBODIA) CO., LTD | 082a581a-c7e5-e614-e063-6394a90a87da | 2023-10-20 | Warnings | M021 |
| Plak Smacker Anti Cavity Fluoride | SODIUM FLUORIDE | YOUNG PS ACQUISITION, LLC | c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe | 2023-10-16 | Warnings | M021 |
| Ionite H | STANNOUS FLUORIDE | Dharma Research, Inc. | 152d84ee-d981-4032-bfb1-a559afe71d40 | 2023-10-11 | Warnings | M021 |
| Sodium Fluoride | SODIUM FLUORIDE | Safco Dental Supply LLC | 788080b3-fff8-4049-af98-f571824994c2 | 2023-10-11 | Warnings | M021 |
| Ionite H | STANNOUS FLUORIDE | Dharma Research, Inc. | 5c312b36-07f4-406e-b3d3-c6d1e964635d | 2023-10-11 | Warnings | M021 |
| Ionite H | STANNOUS FLUORIDE | Dharma Research, Inc. | 042636cf-8b61-4022-b0a1-af09c06b145b | 2023-10-11 | Warnings | M021 |
| Ionite H | STANNOUS FLUORIDE | Dharma Research, Inc. | f4c3569b-7b6a-4566-9e87-492f291c5165 | 2023-10-11 | Warnings | M021 |
| UNITED Asutra TC Kit Colgate | SODIUM MONOFLUOROPHOSPHATE | Procurall Solutions | 042817f9-675f-056a-e063-6394a90a2d97 | 2023-08-30 | Warnings | M021 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 35000-340-63 | 35000034063 | 1 TUBE in 1 CARTON (35000-340-63) / 85 g in 1 TUBE | 1 tube | 2026-10-13 | No | No | Current |