Fluoride
- Product NDC
- 68599-9573
- 11-digit product format
- 685999573
- Labeler code
- 68599
- Product ID
- 68599-9573_5025e58e-e59d-07b6-e063-6394a90ac1e8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- PASTE
- Route
- DENTAL
- Labeler
- McKesson
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-23
- Substance
- SODIUM FLUORIDE
- Active strength
- .22 g/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
- Fluoride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .22 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 245598 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5025e58e-e59c-07b6-e063-6394a90ac1e8 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68599-9573-1 | Fluoride | 24.1 g in 1 TUBE | PASTE | 24.1 | 1 | |
| 68599-9573-2 | Fluoride | 42.5 g in 1 TUBE | PASTE | 42.5 | 1 | |
| 68599-9573-3 | Fluoride | 78 g in 1 TUBE | PASTE | 78 | 1 | |
| 68599-9573-4 | Fluoride | 113.4 g in 1 TUBE | PASTE | 113.4 | 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 |
|---|---|---|---|---|---|---|
| Walgreens Restore and Defend | STANNOUS FLUORIDE | Walgreens | e808ea4b-9081-085b-e053-2a95a90a4f9b | 2026-06-02 | Warnings | M021 |
| Hello Unicorn Splash unicorn splash anticavity fluoride rinse | SODIUM FLUORIDE | Colgate-Palmolive Company | a1014431-7d23-aaff-6dc7-ab58683d0338 | 2026-06-02 | Warnings | M021 |
| Therabreath Anticavity | SODIUM FLUORIDE | Church & Dwight Co., Inc. | feab3d45-ff95-4b32-8258-7d932a7380c9 | 2026-06-01 | Warnings | M021 |
| Orajel Toy Story 5 Anticavity | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 4b80947d-f389-2f80-e063-6294a90abd55 | 2026-06-01 | Warnings | M021 |
| Arm and Hammer | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 54113245-0c1e-739e-e063-6294a90aea42 | 2026-06-01 | Warnings | M021 |
| Arm and Hammer | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 545258fd-8179-fffc-e063-6394a90a467f | 2026-06-01 | Warnings | M021 |
| Orajel Paw Patrol | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 99d87bea-3e99-5d04-e053-2a95a90aaf54 | 2026-06-01 | Warnings | M021 |
| Orajel SuperMario | ANTICAVITY TOOTHPASTE | Church & Dwight Co., Inc. | 27d2f6cb-8661-da9c-e063-6394a90a5bde | 2026-06-01 | Warnings | M021 |
| Orajel KidsToothpaste | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 99d62125-c2c5-5926-e053-2995a90aaa29 | 2026-06-01 | Warnings | M021 |
| AIM CAVITY PROTECTION Multi Benefit | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 1d0f8a33-0b01-40e2-e054-00144ff88e88 | 2026-06-01 | Warnings | M021 |
| Crest plus Tartar Protection Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 560980ea-749f-593d-e063-6394a90a1b9e | 2026-06-01 | Warnings | M021 |
| Colgate Revitalizing White | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | c67223ae-b068-41c5-a15b-7ae9840b93ef | 2026-05-27 | Warnings | M021 |
| Colgate Kids Harry Potter | SODIUM FLUORIDE | Colgate-Palmolive Company | 61c06da4-9f02-4fbc-b80f-1c443e298496 | 2026-05-26 | Warnings | M021 |
| sodium fluoride rinse | SODIUM FLUORIDE RINSE | Rockland Cosmetics, Inc. | 52430b12-4d5f-d1e1-e063-6394a90abd64 | 2026-05-20 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | H E B | d0a52519-3339-40ea-93e5-78f76d348a4d | 2026-05-14 | Warnings, Adverse reactions | M021 |
| Burts Bees Extra White | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | c92524fd-8b93-592d-e053-2a95a90a88c6 | 2026-05-13 | Warnings | M021 |
| MIPaste Plus Strawberry | SODIUM FLUORIDE | GC America Inc. | 1b68bd67-65d3-4c64-e054-00144ff8d46c | 2026-05-12 | Warnings | M021 |
| White Glo Purple Color Corrector Fluoride Anticavity | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | 6f8b77c3-9833-4c75-b41c-a2bc12616157 | 2026-05-12 | Warnings | M021 |
| botalab HERBAL COMPLETE TOOTH | SODIUM FLUORIDE | KMPHARMACEUTICAL CO., LTD. | 51365ef7-ed94-2650-e063-6394a90ab89e | 2026-05-07 | Warnings | M021 |
| Morning Fresh Mint Toothpaste, with Fluoride | MORNING FRESH MINT TOOTHPASTE, WITH FLUORIDE | Dynarex Corporation | 2a42d8ce-e7f2-caa5-e063-6294a90ac01f | 2026-05-07 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 245598 | sodium fluoride 0.22 % Toothpaste | PSN | 5025e58e-e59c-07b6-e063-6394a90ac1e8 | 1 |
| 245598 | sodium fluoride 0.0022 MG/MG Toothpaste | SCD | 5025e58e-e59c-07b6-e063-6394a90ac1e8 | 1 |
| 245598 | sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste | SY | 5025e58e-e59c-07b6-e063-6394a90ac1e8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68599-9573-1 | 68599957301 | 24.1 g in 1 TUBE (68599-9573-1) | 24.1 g | 2026-04-23 | No | No | Current |
| 68599-9573-2 | 68599957302 | 42.5 g in 1 TUBE (68599-9573-2) | 42.5 g | 2026-04-23 | No | No | Current |
| 68599-9573-3 | 68599957303 | 78 g in 1 TUBE (68599-9573-3) | 78 g | 2026-04-23 | No | No | Current |
| 68599-9573-4 | 68599957304 | 113.4 g in 1 TUBE (68599-9573-4) | 113.4 g | 2026-04-23 | No | No | Current |