OTC - ACTIVE INGREDIENT SECTION
Active Ingredient: Sodium Monofluorophosphate (0.76%)
Active Ingredient: Sodium Monofluorophosphate (0.76%)
Purpose: Anticavity
Uses: Aids in the prevention of dental cavities
For external use only. Keep out of reach of children
Keep out of reach of children under six years of age
If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately.
Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or doctor.
Calcium Carbonate, Carboxymethylcellulose Sodium, Flavour, Glycerin, Purified Water, Sodium Benzoate, Sodium Lauryl Sulfate, Hydrated Silica, Saccharin Sodium, Sorbitol, Sodium Pyrophosphate
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | 4 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | 4 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | 4 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | 4 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | 4 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | 4 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54157-103-01 | MegaFresh Fluoride Tooth | 17 g in 1 TUBE | PASTE, DENTIFRICE | 17 | 4 | |
| 54157-103-02 | MegaFresh Fluoride Tooth | 24 g in 1 TUBE | PASTE, DENTIFRICE | 24 | 4 | |
| 54157-103-03 | MegaFresh Fluoride Tooth | 35 g in 1 TUBE | PASTE, DENTIFRICE | 35 | 4 | |
| 54157-103-04 | MegaFresh Fluoride Tooth | 43 g in 1 TUBE | PASTE, DENTIFRICE | 43 | 4 | |
| 54157-103-05 | MegaFresh Fluoride Tooth | 50 g in 1 TUBE | PASTE, DENTIFRICE | 50 | 4 | |
| 54157-103-06 | MegaFresh Fluoride Tooth | 70 g in 1 TUBE | PASTE, DENTIFRICE | 70 | 4 | |
| 54157-103-07 | MegaFresh Fluoride Tooth | 78 g in 1 TUBE | PASTE, DENTIFRICE | 78 | 4 | |
| 54157-103-08 | MegaFresh Fluoride Tooth | 90 g in 1 TUBE | PASTE, DENTIFRICE | 90 | 4 | |
| 54157-103-09 | MegaFresh Fluoride Tooth | 100 g in 1 TUBE | PASTE, DENTIFRICE | 100 | 4 | |
| 54157-103-10 | MegaFresh Fluoride Tooth | 120 g in 1 TUBE | PASTE, DENTIFRICE | 120 | 4 | |
| 54157-103-11 | MegaFresh Fluoride Tooth | 130 g in 1 TUBE | PASTE, DENTIFRICE | 130 | 4 | |
| 54157-103-12 | MegaFresh Fluoride Tooth | 150 g in 1 TUBE | PASTE, DENTIFRICE | 150 | 4 | |
| 54157-103-13 | MegaFresh Fluoride Tooth | 181 g in 1 TUBE | PASTE, DENTIFRICE | 181 | 4 | |
| 54157-103-14 | MegaFresh Fluoride Tooth | 200 g in 1 TUBE | PASTE, DENTIFRICE | 200 | 4 | |
| 54157-103-15 | MegaFresh Fluoride Tooth | 3 g in 1 POUCH | PASTE, DENTIFRICE | 3 | 4 | |
| 54157-103-16 | MegaFresh Fluoride Tooth | 5 g in 1 POUCH | PASTE, DENTIFRICE | 5 | 4 | |
| 54157-103-17 | MegaFresh Fluoride Tooth | 10 g in 1 POUCH | PASTE, DENTIFRICE | 10 | 4 | |
| 54157-103-18 | MegaFresh Fluoride Tooth | 4.25 g in 1 POUCH | PASTE, DENTIFRICE | 4.25 | 4 | |
| 54157-103-19 | MegaFresh Fluoride Tooth | 71 g in 1 TUBE | PASTE, DENTIFRICE | 71 | 4 | |
| 54157-103-20 | MegaFresh Fluoride Tooth | 85 g in 1 TUBE | PASTE, DENTIFRICE | 85 | 4 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM MONOFLUOROPHOSPHATE | ACTIVE INGREDIENT | C810JCZ56Q | 4 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 4 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 4 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 4 | |
| HYDRATED SILICA | INACTIVE INGREDIENT | Y6O7T4G8P9 | 4 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 4 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 4 | |
| SODIUM PYROPHOSPHATE | INACTIVE INGREDIENT | O352864B8Z | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54157-103 | 54157-103-01, 54157-103-02, 54157-103-03, 54157-103-04, 54157-103-05, 54157-103-06, 54157-103-07, 54157-103-08, 54157-103-09, 54157-103-10, 54157-103-11, 54157-103-12, 54157-103-13, 54157-103-14, 54157-103-15, 54157-103-16, 54157-103-17, 54157-103-18, 54157-103-19, 54157-103-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM MONOFLUOROPHOSPHATE | C810JCZ56Q | ACTIM |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM PYROPHOSPHATE | O352864B8Z | 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 |
|---|---|---|---|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GEL / DENTAL | 0.4 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | LOTION / TOPICAL | 111 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, COATED / ORAL | 123 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / DENTAL | NA | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION/ DROPS / OPHTHALMIC | 2 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET / ORAL | 30 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / TOPICAL | 214 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, COATED / ORAL | 64.8 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | POWDER / VAGINAL | 3 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, EXTENDED RELEASE / ORAL | 229.7 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, DELAYED RELEASE / ORAL | 46 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 100 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SHAMPOO, SUSPENSION / TOPICAL | 40 %w/v | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SUSPENSION/ DROPS / ORAL | 12.85 mg/2.5ml | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | GUM, CHEWING / BUCCAL | 3492 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | CONCENTRATE / ORAL | 6 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | FILM / BUCCAL | 18 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RESPIRATORY (INHALATION) | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | ELIXIR / ORAL | 15 mg/5ml | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, FILM COATED / ORAL | 300 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | POWDER, FOR SUSPENSION / ORAL | 64 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYSTEM / TOPICAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, CHEWABLE / ORAL | 6 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / INTRAVENOUS | 4050 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 3 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, FOR SUSPENSION / ORAL | 120 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, CHEWABLE / ORAL | 24.75 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| SODIUM PYROPHOSPHATE | SODIUM PYROPHOSPHATE | O352864B8Z | PASTE, DENTIFRICE / DENTAL | 1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION / INTRAMUSCULAR | 30 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / OPHTHALMIC | 1 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / INTRA-ARTICULAR | 30 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / RECTAL | 406 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / ORAL | 3480 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FOR SUSPENSION / ORAL | 6 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | DROPS / ORAL | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SUSPENSION / ORAL | 160 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SPONGE / TOPICAL | NA |
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 |
|---|---|---|---|---|---|---|
| def7e93e-088f-45ca-90bd-8146eda23abb | c40be43e-3da9-441b-8cde-82a471b94012 | 2015-01-16 | Warnings | def7e93e-088f-45ca-90bd-8146eda23abb c40be43e-3da9-441b-8cde-82a471b94012 |
Adverse event summaries are temporarily unavailable. Other product information remains available.