HEB

Product NDC
37808-896
Requested package NDC
37808-896-29
11-digit product format
378080896
Labeler code
37808
Product ID
37808-896_f2041946-915c-7b8c-e053-2a95a90a22fb
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
HEB
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-10-01
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage37808-89637808-896-29IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
07cba15c-4adc-1039-9ab9-45f5b7e84f4fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-896-292025-01-30C16284748780-12cef2736-59c9-d83d-e063-dadaa90ab31fHEB Brilliant White Dazzling Mint
37808-896-692025-01-30C16284748780-12cef2736-59c9-d83d-e063-dadaa90ab31fHEB Brilliant White Dazzling Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-896-29HEBBrilliant White1 in 1 CARTONPASTE, DENTIFRICE110
37808-896-29HEBBrilliant White141.7 g in 1 TUBEPASTE, DENTIFRICE141.710
37808-896-69HEBBrilliant White1 in 1 CARTONPASTE, DENTIFRICE110
37808-896-69HEBBrilliant White156 g in 1 TUBEPASTE, DENTIFRICE15610

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QHEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3
FLUORIDE IONACTIVE MOIETYQ80VPU408OHEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KHEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JHEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9HEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3
PEG/PPG-116/66 COPOLYMERINACTIVE INGREDIENTJP0CK963E0HEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNHEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9HEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZHEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4HEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-896HEB BRILLIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [HEB]10Legacy NDC, 4 package rows20230113_681dd1e8-e00b-4e56-b950-04976203513c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN681dd1e8-e00b-4e56-b950-04976203513c10
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD681dd1e8-e00b-4e56-b950-04976203513c10
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY681dd1e8-e00b-4e56-b950-04976203513c10
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY681dd1e8-e00b-4e56-b950-04976203513c10
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY681dd1e8-e00b-4e56-b950-04976203513c10
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY681dd1e8-e00b-4e56-b950-04976203513c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-896-29378080896291 TUBE in 1 CARTON (37808-896-29) > 141.7 g in 1 TUBE1 tube2019-02-210000-00-00NoNoCurrent