Websitewww.leveloralcare.com
www.leveloralcare.com
www.leveloralcare.comLevel Anticavity
- Manufacturer
- Level Oral Care, LLC | AmLion Toothpaste Mfg. Sdn. Bhd.
- Effective date
- 2011-05-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-05-31 22:28:00
Label at a glance#
ProductLevel Anticavity
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure13 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient: Purpose
Sodium monofluorophoshate 0.76 percent Anticaries
OTC - PURPOSE SECTION
Purpose
Anticaries
Anticaries
INDICATIONS & USAGE SECTION
Uses:
Aids in the prevention of dental cavities.
WARNINGS SECTION
Warnings:
Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach children under 6 years of age.
DOSAGE & ADMINISTRATION SECTION
Directions:
Adults and children 2 years of age and older: Apply Level Toothpaste onto a soft bristle toothbrush. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
Children under 6 years of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Use a pea-sized amount. Supervise children as necessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: purified water, glycerin, sorbitol, xylitol hydrated silica, calcium carbonate,
tetrasodium pyrophosphate, sodium lauryl sulfate, sodium bicarbonate, sodium saccharin,
cellulose gum, sodium benzoate, flavor
DESCRIPTION SECTION
xylitol
Natural Enamel Protection
True Protection with fluoride
Gentle, yet powerful whitening agents
Ultimate freshness formula
Enamel Guard with pH stabilizers
Distributed by:
Level Oral Care, LLC
Jacksonville, FL 32246
www.leveloralcare.comProduct of MY
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Level
Mint Five
Anticavity Toothpaste
perfect your smile
NET WT 5.0 oz (141.7 g)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DOSAGE FORMS & STRENGTHS SECTION
Level
Mint One
Anticavity Toothpaste
perfect your smile
NET WT 1.0 oz (28.3 g)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | 9 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | 9 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | 9 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | 9 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | 9 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | 9 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50001-111-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8821-f424-e053-dadaa90a57ce | Level Mint Anticavity Toothpaste |
| 50001-111-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8821-f424-e053-dadaa90a57ce | Level Mint Anticavity Toothpaste |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50001-111-10 | Level Anticavity | 28.3 g in 1 TUBE | PASTE | 28.3 | 9 | |
| 50001-111-50 | Level Anticavity | 141.7 g in 1 TUBE | PASTE | 141.7 | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM MONOFLUOROPHOSPHATE | ACTIVE INGREDIENT | C810JCZ56Q | 9 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 9 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 9 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 9 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 9 | |
| SACCHARIN | INACTIVE INGREDIENT | FST467XS7D | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 9 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 9 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | 9 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 9 | |
| SODIUM PYROPHOSPHATE | INACTIVE INGREDIENT | O352864B8Z | 9 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 9 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | 9 |
Products#
Every source-derived product name is available through these pages.
- Level Anticavity
- SODIUM MONOFLUOROPHOSPHATE
- FLUORIDE ION
- WATER
- GLYCERIN
- SORBITOL
- XYLITOL
- SILICON DIOXIDE
- CALCIUM CARBONATE
- SODIUM PYROPHOSPHATE
- SODIUM LAURYL SULFATE
- SODIUM BICARBONATE
- SACCHARIN
- CROSCARMELLOSE SODIUM
- SODIUM BENZOATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50001-111 | 50001-111-50, 50001-111-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM MONOFLUOROPHOSPHATE | C810JCZ56Q | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| SODIUM PYROPHOSPHATE | O352864B8Z | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| SACCHARIN | FST467XS7D | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | 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 |
|---|---|---|---|---|---|---|
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE / ORAL | 257 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRA-ARTICULAR | 45 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE, DENTIFRICE / DENTAL | 0.5 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ENEMA / RECTAL | 60 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, ORALLY DISINTEGRATING / ORAL | 184 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %w/v | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, EXTENDED RELEASE / ORAL | 2752 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | GRANULE, EFFERVESCENT / ORAL | 267 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SHAMPOO / TOPICAL | 65 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / TOPICAL | 0.1 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | OINTMENT / TOPICAL | 14 mg | ||
| SACCHARIN | SACCHARIN | FST467XS7D | SOLUTION / ORAL | 150 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PELLET / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | DROPS / ORAL | NA | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET / BUCCAL | 42 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET / ORAL | 793 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CAPSULE / ORAL | 8.5 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SUSPENSION / ORAL | 705 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | INSERT / VAGINAL | 15 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, CHEWABLE / ORAL | 140 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, COATED / ORAL | 10.6 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | GEL / VAGINAL | 0.2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | GUM, CHEWING / BUCCAL | 11915 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE / DENTAL | 0.08 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, EFFERVESCENT / ORAL | 57600 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 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 |
|---|---|---|---|---|---|---|
| 347f2743-075b-46c7-82ad-19e4d5ba42b3 | e968f453-0f8e-4ede-a42d-835b94d0ae56 | 2011-05-11 | Warnings | 347f2743-075b-46c7-82ad-19e4d5ba42b3 e968f453-0f8e-4ede-a42d-835b94d0ae56 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.