Sensitive Whitening Tooth-paste

Product NDC
79481-0008
11-digit product format
794810008
Labeler code
79481
Product ID
79481-0008_e9579105-80a5-440e-8da2-b31b65542f32
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Meijer, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-24
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 2.43 mg/g; mg/g
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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage79481-0008-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage79481-0008-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage79481-0008-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage79481-0008-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage79481-0008-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage79481-0008-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage79481-0008-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage79481-0008-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage79481-0008-1UExcluded because listing certification expired0efc9e666f02…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
Sensitive Whitening Tooth-paste
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE2.43 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal 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
c25b6a95-e604-48e3-bc55-595969d1ce9bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0008-1Sensitive Whitening Tooth-paste113 g in 1 TUBEPASTE, DENTIFRICE1134
79481-0008-1Sensitive Whitening Tooth-paste1 in 1 BOXPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0008SENSITIVE WHITENING TOOTH-PASTE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [MEIJER, INC.]3Current NDC, Legacy NDC, 2 package rows20230112_c25b6a95-e604-48e3-bc55-595969d1ce9b.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 9 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wintergreen PeppermintPOTASSIUM NITRATE, SODIUM FLUORIDETwice Twice LLC7b7beec2-e070-4102-a2a4-68c332fc9fb32026-01-19WarningsExact identifier
application number: M022
GuruNanda SensitivePOTASSIUM NITRATEGURUNANDA, LLC3ef0d3d4-fd42-0181-e063-6394a90af09c2026-01-19WarningsExact identifier
application number: M022
Up and Up AntisepticCETYLPYRIDINIUM CHLORIDETarget Corporation386ee9f9-598e-ad00-e063-6394a90aeb462026-01-19WarningsExact identifier
application number: M022
Colgate Sensitive Complete ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company4a8f1d2f-b326-46d2-8914-d65ccc409edf2026-01-18WarningsExact identifier
application number: M022
Colgate Sensitive WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company3b656928-af58-4ee9-8fb8-360688eb9bf32026-01-13WarningsExact identifier
application number: M022
Colgate Sensitive Enamel HealthPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Companya50d4259-8a79-417e-b381-72c7a8ec04182026-01-13WarningsExact identifier
application number: M022
Walgreens Sensitive Enamel RepairSODIUM FLUORIDEWalgreens41d6384d-695b-b60b-e063-6394a90aa0b92026-01-09WarningsExact identifier
application number: M022
HyVee Throat Drops Lemon MintMENTHOLHY-VEE, INC47f738cc-7968-cc07-e063-6294a90af7ab2026-01-09WarningsExact identifier
application number: M022
CVS Health Clinical White Stain ProtectorSODIUM FLUORIDECVS Pharmacy41d5c3a9-abe5-5528-e063-6294a90ada792026-01-09WarningsExact identifier
application number: M022
CVS Health Sensitive Enamel RepairSODIUM FLUORIDECVS41d547b3-2feb-8e83-e063-6294a90ae3cd2026-01-09WarningsExact identifier
application number: M022
Moon Platinum Advanced Whitening AnticavitySODIUM FLUORIDEMoon Oral Care LLCded3a5a6-2883-f3de-e053-2a95a90afb942026-01-09WarningsExact identifier
application number: M022
Moon Whitening AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0bdcad3e-b8e9-bd91-e063-6394a90a666a2026-01-09WarningsExact identifier
application number: M022
Colgate Sensitive Prevent and RepairPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Companye67410dc-a671-4611-8af1-097be071cd1c2026-01-09WarningsExact identifier
application number: M022
Colgate Sensitive plus WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company2092c747-e025-47a9-9e54-731631d3c8312026-01-09WarningsExact identifier
application number: M022
Dentemp Canker CoverCANKER COVERDOC Brands2e7fbf9d-553c-c7bf-e063-6294a90a5f792026-01-08WarningsExact identifier
application number: M022
HyVee Throat Drops Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.47e2650f-4f50-8d85-e063-6394a90a1ddc2026-01-08WarningsExact identifier
application number: M022
Dentemp Canker CoverCANKER COVERDOC Brands2b4b22e9-a03b-fb8f-e063-6394a90a87472026-01-08WarningsExact identifier
application number: M022
Crest 3D White AdvancedSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyf3aa9a59-b4d4-05d9-e053-2995a90a0aea2026-01-08Exact identifier
application number: M022
Oral B Plaque Defense Special Care Oral RinseCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd503fad5-a378-0e60-e053-2a95a90abe652026-01-08WarningsExact identifier
application number: M022
Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All DayCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd5f69341-b659-c74a-e053-2a95a90a317e2026-01-08WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.14 % - 0.15 % ) ToothpastePSNc25b6a95-e604-48e3-bc55-595969d1ce9b4
1038800potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG ToothpasteSCDc25b6a95-e604-48e3-bc55-595969d1ce9b4
1038800K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSYc25b6a95-e604-48e3-bc55-595969d1ce9b4
1038800Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSYc25b6a95-e604-48e3-bc55-595969d1ce9b4
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYc25b6a95-e604-48e3-bc55-595969d1ce9b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79481-0008-1794810008011 TUBE in 1 BOX (79481-0008-1) / 113 g in 1 TUBE1 tube2020-12-240000-00-00NoNoCurrent