FDA.reportPublic FDA data

CVS Pharmacy

Product NDC
59779-815
11-digit product format
597790815
Labeler code
59779
Product ID
59779-815_441c8aa1-97f6-c07c-e063-6294a90aeec0
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
CVS Pharmacy
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-10-01
Substance
POTASSIUM NITRITE; SODIUM FLUORIDE
Active strength
5; .15 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CVS Pharmacy
Brand name suffix
Enamel Guard
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRITE5 g/100g
SODIUM FLUORIDE.15 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii794654G42L, 8ZYQ1474W7
Rxcui1038800

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
70dd82cf-c501-052d-5d98-d42ef9849750Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-815-42CVS PharmacyEnamel Guard113 g in 1 TUBEPASTE, DENTIFRICE1139
59779-815-49CVS PharmacyEnamel Guard1 in 1 CARTONPASTE, DENTIFRICE19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRITEACTIVE INGREDIENT794654G42LCVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7CVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
NITRITE IONACTIVE MOIETYJ39976L608CVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
SORBITOLINACTIVE INGREDIENT506T60A25RCVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RCVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-815CVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]6Current NDC, Legacy NDC, 2 package rows20250120_18295a1c-c2a6-489b-be34-9252b9e1e2b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.14 % - 0.15 % ) ToothpastePSN18295a1c-c2a6-489b-be34-9252b9e1e2b89
1038800potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG ToothpasteSCD18295a1c-c2a6-489b-be34-9252b9e1e2b89
1038800K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY18295a1c-c2a6-489b-be34-9252b9e1e2b89
1038800Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY18295a1c-c2a6-489b-be34-9252b9e1e2b89
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY18295a1c-c2a6-489b-be34-9252b9e1e2b89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-815-4259779081542113 g in 1 TUBE113 gHistorical
59779-815-49597790815491 TUBE in 1 CARTON (59779-815-49) / 113 g in 1 TUBE (59779-815-42) 1 tube2013-01-070000-00-00NoNoCurrent