Evernamel

Manufacturer
Alpine Dental, Inc. | Dharma Research, Inc.
Effective date
2023-01-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:53:25

Label at a glance#

ProductEvernamel
Active ingredientSTANNOUS FLUORIDE
Label structure10 sections

Indications and uses

• Builds up the enamel of teeth • Aids in the prevention of cavities • Helps prevent gingivitis • Helps sensitive teeth

Dosage and administration

• Remove seal • Apply a pea-sized amount of paste to the wet toothbrush Adults and Children 12 years or older: • Brush teeth thoroughly for one minute after ach meal at least twice a day (or as directed by a dentist or physician) • Do not swallow Children under 12 years of age: ask a dentist

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Stannous Fluoride, 0.454%

Purpose

OTC - PURPOSE SECTION

Anti-cavity & Anti-gingivitis

Uses

INDICATIONS & USAGE SECTION

• Builds up the enamel of teeth
• Aids in the prevention of cavities
• Helps prevent gingivitis
• Helps sensitive teeth

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 12 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Remove seal
• Apply a pea-sized amount of paste to the wet toothbrush

Adults and Children 12 years or older:
• Brush teeth thoroughly for one minute after ach meal at least twice a day (or as directed by a dentist or physician)
• Do not swallow

Children under 12 years of age: ask a dentist

Other Information

SPL UNCLASSIFIED SECTION

• Everest enamel was specially formulated to prevent surface stains on the teeth, which otherwise can occur while using Stannous Fluoride.

• Adequate tooth brushing may also prevent Stannous Fluoride stains which are not harmful or permanent and can be removed by a Dentist

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Sodium Gluconate, Flavor, Zinc Citrate, Quillaja Saponica Bark Extract, Cocamidopropyl Betaine, Titanium Dioxide, Smilax Aristolochiaefolia Root Extract, Sodium Hydroxide, Sodium Hydroxide, Sodium Tripolyphosphate, Tocopheryl Acetate, Xanthan Gum, Natural Menthol, Yucca Schidigera Rooth Extract, Dioscorea Villosa Root Extract

Questions or comments?

SPL UNCLASSIFIED SECTION

Call toll free 1-800-553-3682

SPL UNCLASSIFIED SECTION

Manufactured for:

Alpine Dental, Inc.

Brooklyn, NY 11218

Made in the USA

Item Code 1520-10

Evernamel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Brush Your Way To a Brighter Smile

Fresh Spearmint

Evernamel

Toothpaste with Remineralizing Benefits

Anticavity / Antigingivitis / Sensitivity Relief

122 g / 4.3 oz.

20230123_83199_102_4320230123_83199_102_43

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN1
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD1
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY1
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY1
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83199-102-432025-01-30C16284748780-12cef2736-a6dc-d83d-e063-dadaa90ab31f09ff59d9-046e-47f3-950d-c0a2f8943364

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83199-102-43Evernamel122 g in 1 TUBEPASTE, DENTIFRICE1221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83199-102EVERNAMEL (STANNOUS FLUORIDE) PASTE, DENTIFRICE [ALPINE DENTAL, INC.]11 package rows20230124_09ff59d9-046e-47f3-950d-c0a2f8943364.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83199-10283199-102-43

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ad1826fa-f665-473c-aaca-79cf9921914f09ff59d9-046e-47f3-950d-c0a2f89433642023-01-23WarningsExact identifier
spl id: ad1826fa-f665-473c-aaca-79cf9921914f
spl set id: 09ff59d9-046e-47f3-950d-c0a2f8943364

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.