Cardinal Health Fluoride Anticavity

Product NDC
63517-016
11-digit product format
635170016
Labeler code
63517
Product ID
63517-016_1ab1ab30-2c3b-478f-9c9a-b28b058828ad
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride Anticavity Toothpaste
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Cardinal Health
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-09-09
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
2 mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63517-016DDiscontinued by firm2026-08-17
excluded packagepackage63517-01663517-016-96DDiscontinued by firm2026-08-17

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 · 36 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63517-016-96DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63517-016-96DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63517-016-96DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63517-016-96DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63517-016-96DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63517-016-96DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63517-016-96DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63517-016-96DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63517-016-96DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63517-016-96IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63517-016-96IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63517-016-96IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63517-016-96IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63517-016-96IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63517-016-96IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63517-016-96IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63517-016-96IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63517-016-96IInactivated by FDAbd6a592717d7…303034d00443…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63517-016-962024-11-12C16284748780-1d6a99b39-6d34-a426-e053-dadaa90af4c2cd5570d9-83b6-441b-a0c1-43d95b6b61f4
63517-016-962022-01-28C16284748780-1d6a99b39-6d34-a426-e053-dadaa90af4c2cd5570d9-83b6-441b-a0c1-43d95b6b61f4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7CARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XCARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1
PEG-6 STEARATEINACTIVE INGREDIENT8LQC57C6B0CARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FCARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1
SORBITOLINACTIVE INGREDIENT506T60A25RCARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1
WATERINACTIVE INGREDIENT059QF0KO0RCARDINAL HEALTH FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [CARDINAL HEALTH]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63517-016-9663517001696144 TUBE in 1 CASE (63517-016-96) > 24 g in 1 TUBE144 tube2013-09-090000-00-00NoNoCurrent