Indications and uses
Helps protect against cavitites.
Helps protect against cavitites.
adults and children 12 years and older: brush teeth thoroughly, preferably after each meal, or at least twice a day, or as directed by your dentist. do not swallow. children under 6 years of age: to minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. children under 2 years of age: ask a dentist or physician.
Sodium monofluorophosphate 0.76%................Anticavity (0.15% w/v fluoride ion)
glycerin, water, calcium carbonate, hydrated silica, xylitol, cellulose gum, cocamidopropyl betaine, flavour peppermint oil, sodium bicarbonate, zinc citrate, sucralose.
as with all fluoride toothpastes, keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.
keep out of reach of children under 6 years of age.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | 1 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | 1 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | 1 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | 1 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | 1 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | 1 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-2008-01 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e5ac-cd31-e053-dbdaa90ab51a | Ology Fluoride Toothpaste |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-2008-01 | Ology Fluoride | 133 g in 1 TUBE | PASTE | 133 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM MONOFLUOROPHOSPHATE | ACTIVE INGREDIENT | C810JCZ56Q | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 1 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 1 | |
| COCAMIDOPROPYL BETAINE | INACTIVE INGREDIENT | 5OCF3O11KX | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HYDRATED SILICA | INACTIVE INGREDIENT | Y6O7T4G8P9 | 1 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | 1 | |
| ZINC CITRATE | INACTIVE INGREDIENT | K72I3DEX9B | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0363-2008 | 0363-2008-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM MONOFLUOROPHOSPHATE | C810JCZ56Q | ACTIM |
| GLYCERIN | PDC6A3C0OX | IACT |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| ZINC CITRATE | K72I3DEX9B | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SUSPENSION / ORAL | 400 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / ORAL | 45 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | GUM, CHEWING / BUCCAL | 3492 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET / ORAL | 793 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, EFFERVESCENT / ORAL | 57600 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, CHEWABLE / ORAL | 1650 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SUSPENSION, EXTENDED RELEASE / ORAL | 9000 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, COATED / ORAL | 64.8 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY, METERED / NASAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, CHEWABLE / ORAL | 140 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, ORALLY DISINTEGRATING / ORAL | 107 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | POWDER, DENTIFRICE / DENTAL | 0.5 mg/mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION / ORAL | 383 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, ORALLY DISINTEGRATING / ORAL | 60 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | SOLUTION / INTRAVENOUS | 4.02 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, DELAYED RELEASE / ORAL | 30 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, COATED / ORAL | 10.6 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EFFERVESCENT / ORAL | 1080 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SOLUTION / ORAL | 414 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / SUBLINGUAL | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GUM, CHEWING / BUCCAL | 70 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 72 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET / ORAL | 1300 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY / NASAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE, EXTENDED RELEASE / ORAL | 4 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | SOLUTION / AURICULAR (OTIC) | 0.38 %w/w | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | CAPSULE / ORAL | 320 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | PASTE / ORAL | 180 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION / SUBCUTANEOUS | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg |
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 |
|---|---|---|---|---|---|---|
| e9831cf9-73cb-475e-9a06-dc6c6b0eb5ce | 69bccfc6-f9a7-497c-aae6-104dc3d97d76 | 2013-03-21 | Warnings | e9831cf9-73cb-475e-9a06-dc6c6b0eb5ce 69bccfc6-f9a7-497c-aae6-104dc3d97d76 |
Adverse event summaries are temporarily unavailable. Other product information remains available.