FDA.reportPublic FDA data

CVS

Product NDC
59779-122
11-digit product format
597790122
Labeler code
59779
Product ID
59779-122_441cb2ce-3624-84e2-e063-6394a90a732c
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
CVS Pharmacy
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-01-20
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.15; 5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59779-12259779-122-29DDiscontinued by firm2026-10-05

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 · 1 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-12259779-122-29DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
Brand name suffix
Extra Whitening
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.15 g/100g
POTASSIUM NITRATE5 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
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b019849-6585-4a8c-a90a-c7e9e617b3efAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-122-22CVSExtra Whitening113 g in 1 TUBEPASTE, DENTIFRICE11310
59779-122-29CVSExtra Whitening1 in 1 CARTONPASTE, DENTIFRICE110
59779-122-39CVSExtra Whitening1 in 1 CARTONPASTE, DENTIFRICE110
59779-122-39CVSExtra Whitening113 g in 1 TUBEPASTE, DENTIFRICE11310

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZCVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7CVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
NITRATE IONACTIVE MOIETYT93E9Y2844CVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GCVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
SODIUM TRIPOLYPHOSPHATEINACTIVE INGREDIENT5HK03SA80JCVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
SORBITOLINACTIVE INGREDIENT506T60A25RCVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RCVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-122CVS EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]8Current NDC, Legacy NDC, 4 package rows20250119_3b019849-6585-4a8c-a90a-c7e9e617b3ef.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 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CrystLCare Regeneration PlusPOTASSIUM NITRATE, SODIUM FLUORIDEGreenMark Biomedical Inc.4f86d0a0-d73e-5605-e063-6394a90adb382026-09-14WarningsExact identifier
application number: M022
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
application number: M022
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
application number: M022
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
application number: M022
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
application number: M022
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
application number: M022
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
application number: M022
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEAmerisourceBergen (Good Neighbor Pharmacy) 461220733015b-e81a-4a62-82ad-dacaf3f163cb2026-09-02WarningsExact identifier
application number: M022
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORTHEXYLRESORCINOLReckitt Benckiser LLC91cd2964-5d83-4e40-bc18-e3e5462f454a2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
application number: M022
LUDENS SUGAR FREE WILD CHERRY THROATPECTINPrestige Brands Holdings, Inc.274fc80c-e5b2-41c7-a119-287d6e8a22582026-08-28WarningsExact identifier
application number: M022
Medline Peroxi Fresh MouthwashHYDROGEN PEROXIDEMedline Industries, LPec7a9240-6c66-4471-b8b6-776e08a14fbc2026-08-27WarningsExact identifier
application number: M022
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN3b019849-6585-4a8c-a90a-c7e9e617b3ef10
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD3b019849-6585-4a8c-a90a-c7e9e617b3ef10
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY3b019849-6585-4a8c-a90a-c7e9e617b3ef10
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY3b019849-6585-4a8c-a90a-c7e9e617b3ef10
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3b019849-6585-4a8c-a90a-c7e9e617b3ef10
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3b019849-6585-4a8c-a90a-c7e9e617b3ef10
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY3b019849-6585-4a8c-a90a-c7e9e617b3ef10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-122-2259779012222113 g in 1 TUBE113 gHistorical
59779-122-29597790122291 TUBE in 1 CARTON (59779-122-29) > 113 g in 1 TUBE (59779-122-22) 1 tube2012-11-050000-00-00NoNoCurrent
59779-122-39597790122391 TUBE in 1 CARTON (59779-122-39) / 113 g in 1 TUBE1 tube2025-11-21NoNoCurrent