PRO-SYS
- Product NDC
- 66975-720
- 11-digit product format
- 669750720
- Labeler code
- 66975
- Product ID
- 66975-720_4e53a23c-7977-632d-e063-6394a90a7ae6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL; ORAL
- Labeler
- Benco Dental
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-12-01
- Substance
- SODIUM FLUORIDE
- Active strength
- .11 g/100g
- 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
- PRO-SYS
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .11 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 416783 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4e539cb2-bcbd-95fc-e063-6294a90a2121 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66975-720-01 | PRO-SYS | 113.4 g in 1 TUBE | PASTE, DENTIFRICE | 113.4 | 1 | |
| 66975-720-02 | PRO-SYS | 24 g in 1 TUBE | PASTE, DENTIFRICE | 24 | 1 |
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 |
|---|---|---|---|---|---|---|
| TheraBreath Kids Anticavity Oral Rinse Bubblegum | ANTICAVITY ORAL RINSE | Church & Dwight Co., Inc. | 2770424d-7416-66d4-e063-6394a90ad4b1 | 2026-02-06 | Warnings | M021 |
| Crest Pro-Health Sensitivity Whitening Plus Scope | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | 463b7820-a5ce-f8b5-e063-6394a90aa018 | 2026-02-05 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Publix Super Markets, Inc. | 14494238-872b-49e2-8bf7-df3844a0a6c8 | 2026-02-05 | Warnings, Adverse reactions | M021 |
| HAPEE EXPLOSIVE MENTHOL RED 150 | SODIUM MONOFLUOROPHOSPHATE | LAMOIYAN CORPORATION | 14c14694-6149-40a8-aff2-660d39f7e0c1 | 2026-02-05 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | HARRIS TEETER | f759e9e4-6de2-4b80-903b-e67c06e36295 | 2026-02-04 | Warnings, Adverse reactions | M021 |
| Oral Antivavity | SODIUM FLUORIDE | HARRIS TEETER | 571f7628-fd59-462f-96dd-67aeaa98cff1 | 2026-02-04 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Lidl US, LLC | c47475aa-3125-410f-aa31-0add6e4ce125 | 2026-02-04 | Warnings, Adverse reactions | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Demoulas Super Markets, Inc | 6391ca2e-10e8-429d-a873-238a515f9c60 | 2026-02-03 | Warnings, Adverse reactions | M021 |
| Crest 3D White Brilliance Pro Ultra White | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | f4c02924-95ee-09d2-e053-2995a90a8121 | 2026-02-03 | M021 | |
| Crest 3D White Stain Eraser Icy Clean Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f5d97011-7be3-3b1c-e053-2a95a90ade86 | 2026-02-03 | M021 | |
| Anticavity | SODIUM FLUORIDE | Demoulas Super Markets, Inc. | c28c3475-efbb-4099-83ab-ab91bac9dfc3 | 2026-02-03 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Demoulas Super Markets, Inc | 65abfb4d-3a1e-42df-b343-f270ce60a3bf | 2026-02-03 | Warnings, Adverse reactions | M021 |
| Crest Cavity Protection Cool Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 102e4d9c-0fae-d48a-e063-6294a90aac94 | 2026-02-03 | Warnings | M021 |
| Crest Plus Tartar Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 08767b0f-ed6e-8d32-e063-6294a90a10cd | 2026-02-03 | Warnings | M021 |
| Crest Braces Care Anticavity Fluoride Rinse | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d8398cfd-9af6-690d-e053-2995a90a9b7c | 2026-02-03 | Warnings | M021 |
| AutoBrush bubblegum | SODIUM FLUORIDE | Lander Enterprises, LLC | 2e85d6f7-2df8-4eb9-bc97-d7b7af7fb460 | 2026-02-03 | Warnings | M021 |
| AutoBrush Mint | SODIUM FLUORIDE | Lander Enterprises, LLC | d859d02d-a036-4d90-bed4-9a5c31e9e1ef | 2026-02-03 | Warnings | M021 |
| Glowing White | SODIUM FLUORIDE | Demoulas Super Markets, Inc | 32faf47d-b64f-4454-9f14-51503504c6b5 | 2026-02-03 | Warnings, Adverse reactions | M021 |
| Sodium fluoride | SODIUM FLUORIDE | Demoulas Super Markets, Inc | 2f5d3c75-1a11-47e1-b297-e2302177efe7 | 2026-02-03 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Demoulas Super Markets, Inc | 096e6a1d-316b-432a-bf27-70e8a13337cc | 2026-02-03 | Warnings, Adverse reactions | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 416783 | sodium fluoride 0.24 % Toothpaste | PSN | 4e539cb2-bcbd-95fc-e063-6294a90a2121 | 1 |
| 416783 | sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 4e539cb2-bcbd-95fc-e063-6294a90a2121 | 1 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste | SY | 4e539cb2-bcbd-95fc-e063-6294a90a2121 | 1 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 4e539cb2-bcbd-95fc-e063-6294a90a2121 | 1 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 4e539cb2-bcbd-95fc-e063-6294a90a2121 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 66975-720-01 | 66975072001 | 113.4 g in 1 TUBE (66975-720-01) | 113.4 g | 2025-12-01 | No | No | Current |
| 66975-720-02 | 66975072002 | 24 g in 1 TUBE (66975-720-02) | 24 g | 2025-12-01 | No | No | Current |