OTC - ACTIVE INGREDIENT SECTION
Active Ingredient: Sodium Fluoride (0.22%)
MegaFresh
- Manufacturer
- American Amenities, Inc.
- Effective date
- 2015-01-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 22:41:24
Label at a glance#
ProductMegaFresh
Active ingredientSODIUM FLUORIDE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Purpose: Anticavity
INDICATIONS & USAGE SECTION
Uses: Aids in the prevention of dental cavities
WARNINGS SECTION
For external use only. Keep out of reach of children
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children under six years of age
OTC - ASK DOCTOR SECTION
If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately.
DOSAGE & ADMINISTRATION SECTION
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.
INACTIVE INGREDIENT SECTION
Purified Water,Sorbitol, Polyethylene Glycol 1500, Carboxymethylcellulose Sodium, Sodium Lauryl Sulfate, Flavour, Carbomer Homopolymer Type C, Hydrated Silica, Saccharin Sodium,Methylparaben, Propylparaben
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54157-102-01 | MegaFresh | 17 g in 1 TUBE | GEL, DENTIFRICE | 17 | 4 | |
| 54157-102-02 | MegaFresh | 24 g in 1 TUBE | GEL, DENTIFRICE | 24 | 4 | |
| 54157-102-03 | MegaFresh | 35 g in 1 TUBE | GEL, DENTIFRICE | 35 | 4 | |
| 54157-102-04 | MegaFresh | 43 g in 1 TUBE | GEL, DENTIFRICE | 43 | 4 | |
| 54157-102-05 | MegaFresh | 50 g in 1 TUBE | GEL, DENTIFRICE | 50 | 4 | |
| 54157-102-06 | MegaFresh | 70 g in 1 TUBE | GEL, DENTIFRICE | 70 | 4 | |
| 54157-102-07 | MegaFresh | 78 g in 1 TUBE | GEL, DENTIFRICE | 78 | 4 | |
| 54157-102-08 | MegaFresh | 90 g in 1 TUBE | GEL, DENTIFRICE | 90 | 4 | |
| 54157-102-09 | MegaFresh | 100 g in 1 TUBE | GEL, DENTIFRICE | 100 | 4 | |
| 54157-102-10 | MegaFresh | 120 g in 1 TUBE | GEL, DENTIFRICE | 120 | 4 | |
| 54157-102-11 | MegaFresh | 130 g in 1 TUBE | GEL, DENTIFRICE | 130 | 4 | |
| 54157-102-12 | MegaFresh | 150 g in 1 TUBE | GEL, DENTIFRICE | 150 | 4 | |
| 54157-102-13 | MegaFresh | 181 g in 1 TUBE | GEL, DENTIFRICE | 181 | 4 | |
| 54157-102-14 | MegaFresh | 200 g in 1 TUBE | GEL, DENTIFRICE | 200 | 4 | |
| 54157-102-15 | MegaFresh | 4.25 g in 1 POUCH | GEL, DENTIFRICE | 4.25 | 4 | |
| 54157-102-16 | MegaFresh | 3 g in 1 POUCH | GEL, DENTIFRICE | 3 | 4 | |
| 54157-102-17 | MegaFresh | 5 g in 1 POUCH | GEL, DENTIFRICE | 5 | 4 | |
| 54157-102-18 | MegaFresh | 10 g in 1 POUCH | GEL, DENTIFRICE | 10 | 4 | |
| 54157-102-19 | MegaFresh | 71 g in 1 TUBE | GEL, DENTIFRICE | 71 | 4 | |
| 54157-102-20 | MegaFresh | 85 g in 1 TUBE | GEL, DENTIFRICE | 85 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | 4 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 4 | |
| CARBOMER HOMOPOLYMER TYPE C | INACTIVE INGREDIENT | 4Q93RCW27E | 4 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 4 | |
| HYDRATED SILICA | INACTIVE INGREDIENT | Y6O7T4G8P9 | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 4 | |
| POLYETHYLENE GLYCOL 1500 | INACTIVE INGREDIENT | 1212Z7S33A | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 4 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Products#
Every source-derived product name is available through these pages.
- MegaFresh
- SODIUM FLUORIDE
- FLUORIDE ION
- WATER
- SORBITOL
- POLYETHYLENE GLYCOL 1500
- CARBOXYMETHYLCELLULOSE SODIUM
- SODIUM LAURYL SULFATE
- CARBOMER HOMOPOLYMER TYPE C
- HYDRATED SILICA
- SACCHARIN SODIUM
- METHYLPARABEN
- PROPYLPARABEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54157-102 | 54157-102-01, 54157-102-02, 54157-102-03, 54157-102-04, 54157-102-05, 54157-102-06, 54157-102-07, 54157-102-08, 54157-102-09, 54157-102-10, 54157-102-11, 54157-102-12, 54157-102-13, 54157-102-14, 54157-102-15, 54157-102-16, 54157-102-17, 54157-102-18, 54157-102-19, 54157-102-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| POLYETHYLENE GLYCOL 1500 | 1212Z7S33A | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| CARBOMER HOMOPOLYMER TYPE C | 4Q93RCW27E | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v | ||
| CARBOMER HOMOPOLYMER TYPE C | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | OINTMENT, AUGMENTED / TOPICAL | 23 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAMUSCULAR | 22 mg | ||
| CARBOMER HOMOPOLYMER TYPE C | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL, METERED / TRANSDERMAL | 50 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | PASTE, DENTIFRICE / DENTAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / NASAL | 14 mg | ||
| POLYETHYLENE GLYCOL 1500 | POLYETHYLENE GLYCOL 1600 | 1212Z7S33A | SUPPOSITORY / RECTAL | 0.3 mg/mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | DROPS / ORAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 25 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RESPIRATORY (INHALATION) | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRALESIONAL | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAVENOUS | 95 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | AEROSOL, FOAM / VAGINAL | 0.2 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SYRUP / ORAL | 24 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION, CONCENTRATE / ORAL | 0.2 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, CHEWABLE / ORAL | 0.14 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FILM COATED / ORAL | 240 mg | ||
| CARBOMER HOMOPOLYMER TYPE C | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | CREAM / TOPICAL | 103 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / OPHTHALMIC | 1 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYRUP / ORAL | 40 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SHAMPOO / TOPICAL | 0.03 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / VAGINAL | 12 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | GEL / TOPICAL | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | POWDER, FOR SOLUTION / ORAL | 161 mg | ||
| POLYETHYLENE GLYCOL 1500 | POLYETHYLENE GLYCOL 1600 | 1212Z7S33A | TABLET / ORAL | 1.2 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FOR SUSPENSION / ORAL | 264 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, EXTENDED RELEASE / ORAL | 0.12 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET / BUCCAL | 4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / OPHTHALMIC | 0.01 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | EMULSION / TOPICAL | 0.06 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYSTEM / TOPICAL | 1680 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SPRAY / TOPICAL | 7 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / ORAL | 233 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, EXTENDED RELEASE / ORAL | 933 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg |
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 |
|---|---|---|---|---|---|---|
| 1e9bad2c-9dd6-43ba-af20-9e7865d450ad | 3ef5fc36-d922-4574-a280-a8ad4a1c763a | 2015-01-16 | Warnings | 1e9bad2c-9dd6-43ba-af20-9e7865d450ad 3ef5fc36-d922-4574-a280-a8ad4a1c763a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.