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 |
|---|---|---|---|---|---|---|
| Hismile | STRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef766ae-754a-f185-e063-6294a90a3299 | 2026-01-15 | Warnings | M021 |
| Hismile | BANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef7be5b-df8f-9f32-e063-6394a90a4724 | 2026-01-15 | Warnings | M021 |
| Hismile | VANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef8d0ef-a051-f610-e063-6394a90a8537 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d40b98b-2e9a-d84a-e063-6294a90a2096 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d44863e-93be-2b80-e063-6294a90a4a9d | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d458ccc-8f1e-f9c8-e063-6294a90a8da4 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d447939-fbf6-42f6-e063-6294a90af6d9 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1de591d9-9cab-e63d-e063-6394a90ac8eb | 2026-01-15 | Warnings | M021 |
| Ice Pop Flavor Sodium Fluoride Anticavity Toothpast | SODIUM FLUORIDE | HISMILE PTY LTD | 20e1603e-bcd1-6a5e-e063-6294a90ad1db | 2026-01-15 | Warnings | M021 |
| Hismile | CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | HISMILE PTY LTD | 1e725b7e-accc-f51c-e063-6394a90a455c | 2026-01-15 | Warnings | M021 |
| Enamelon Preventive Treatment | STANNOUS FLUORIDE | Premier Dental Products Company | 04c3f178-7905-404d-9ac2-67c453287ddf | 2026-01-13 | Warnings | M021 |
| Enamelon | STANNOUS FLUORIDE | Premier Dental Products Company | 1626375a-f78b-4192-b7f3-ca932acab7fb | 2026-01-13 | Warnings | M021 |
| ARU CAVITY PROTECTION | SODIUM FLUORIDE | Ashtel Studios, Inc. | 97bd2934-4bff-4fdb-9199-fcdc0f77fada | 2026-01-13 | Warnings | M021 |
| ACT Anticavity Fluoride Cinnamon | SODIUM FLUORIDE | Chattem, Inc. | f2952ca5-c1c3-42fc-82a4-08662286be44 | 2026-01-12 | Warnings | M021 |
| ACT Anticavity Fluoride Kids Wild Watermelon | SODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION) | Chattem, Inc. | bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a8 | 2026-01-12 | Warnings | M021 |
| ACT Kids Anticavity Fluoride Pineapple Punch | SODIUM FLUORIDE | Chattem, Inc. | 2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b | 2026-01-12 | Warnings | M021 |
| Botao Kids Strawberry Flavored with Fluoride | BOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDE | Peer Pharm Ltd. | 48b8d884-5e15-4145-8521-ae9ee482e392 | 2026-01-12 | Warnings | M021 |
| ACT Total Care Anticavity Fluoride Fresh Mint | SODIUM FLUORIDE | Chattem, Inc. | 4ee6a478-afcf-4540-b427-ba08c942ccb3 | 2026-01-12 | Warnings | M021 |
| ACT Anticavity Fluoride Mint | SODIUM FLUORIDE | Chattem, Inc. | e81c83a2-363a-442f-8731-2598a4f4c21e | 2026-01-12 | Warnings | M021 |
| ACT Total Care Anticavity Fluoride Icy Clean Mint | SODIUM FLUORIDE | Chattem, Inc. | 258b78b4-55e7-410c-90f8-a3e456c02579 | 2026-01-12 | Warnings | 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 |