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
SODIUM FLUORIDE; POTASSIUM NITRITE
Active strength
.15; 5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct59779-815UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59779-81559779-815-49UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

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
SODIUM FLUORIDE.15 g/100g
POTASSIUM NITRITE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
794654G42LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038800Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
18295a1c-c2a6-489b-be34-9252b9e1e2b8Available on FDA.report

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

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 21 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HISMILESODIUM FLUORIDEHISMILE PTY LTD1de591d9-9cab-e63d-e063-6394a90ac8eb2026-01-15WarningsExact identifier
application number: M021
Ice Pop Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD20e1603e-bcd1-6a5e-e063-6294a90ad1db2026-01-15WarningsExact identifier
application number: M021
HismileCANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHISMILE PTY LTD1e725b7e-accc-f51c-e063-6394a90a455c2026-01-15WarningsExact identifier
application number: M021
Enamelon Preventive TreatmentSTANNOUS FLUORIDEPremier Dental Products Company04c3f178-7905-404d-9ac2-67c453287ddf2026-01-13WarningsExact identifier
application number: M021
EnamelonSTANNOUS FLUORIDEPremier Dental Products Company1626375a-f78b-4192-b7f3-ca932acab7fb2026-01-13WarningsExact identifier
application number: M021
ARU CAVITY PROTECTIONSODIUM FLUORIDEAshtel Studios, Inc.97bd2934-4bff-4fdb-9199-fcdc0f77fada2026-01-13WarningsExact identifier
application number: M021
ACT Anticavity Fluoride CinnamonSODIUM FLUORIDEChattem, Inc.f2952ca5-c1c3-42fc-82a4-08662286be442026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids Wild WatermelonSODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION)Chattem, Inc.bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a82026-01-12WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Pineapple PunchSODIUM FLUORIDEChattem, Inc.2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b2026-01-12WarningsExact identifier
application number: M021
Botao Kids Strawberry Flavored with FluorideBOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDEPeer Pharm Ltd.48b8d884-5e15-4145-8521-ae9ee482e3922026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.4ee6a478-afcf-4540-b427-ba08c942ccb32026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride MintSODIUM FLUORIDEChattem, Inc.e81c83a2-363a-442f-8731-2598a4f4c21e2026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.258b78b4-55e7-410c-90f8-a3e456c025792026-01-12WarningsExact identifier
application number: M021
ACT Total Care Dry Mouth Anticavity MouthSODIUM FLUORIDEChattem, Inc.06684b82-aaa0-4ca6-8d56-4f98662690002026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids Groovy GrapeSODIUM FLUORIDEChattem, Inc.cd167c0b-2086-4204-b0ac-90df404bd4bb2026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.beded786-bb55-4ba3-82fe-9e9d1b5e29792026-01-12WarningsExact identifier
application number: M021
ACT Kids Pure Protect Anticavity- Simply StrawberrySODIUM FLUORIDEChattem, Inc.2fc80727-57c7-4a33-80e0-ab9f9487390d2026-01-12WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Groovy GrapeSODIUM FLUORIDEChattem, Inc.310a3c11-1c66-4dac-99f4-5fdc15d0f77c2026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids BubblegumSODIUM FLUORIDEChattem, Inc.fbbccd58-a816-4a93-a658-f28246c11e802026-01-12WarningsExact identifier
application number: M021
ACT Whitening Anticavity Gentle MintSODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION)Chattem, Inc.cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf492026-01-12WarningsExact identifier
application number: M021

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