FDA.reportPublic FDA data

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Product NDC
69968-0478
11-digit product format
699680478
Labeler code
69968
Product ID
69968-0478_eeac0024-2894-84a1-e053-2a95a90a30ac
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Johnson & Johnson Consumer Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-06-01
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 mg/mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69968-0478DDiscontinued by firm2026-10-05
excluded packagepackage69968-047869968-0478-4DDiscontinued by firm2026-10-05
excluded packagepackage69968-047869968-0478-8DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69968-0478-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69968-0478-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69968-0478-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69968-0478-8f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69968-0478-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69968-0478-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69968-0478-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69968-0478-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69968-0478-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69968-0478-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69968-0478-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69968-0478-8cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69968-0478-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69968-0478-8302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69968-0478-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69968-0478-8ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69968-0478-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69968-0478-80efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-0478-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69968-0478-8ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0478-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69968-0478-8367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69968-0478-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69968-0478-8557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0478-469968047804400 mL in 1 BOTTLE, PLASTIC (69968-0478-4) 400 ml2018-06-010000-00-00NoNoCurrent
69968-0478-869968047808800 mL in 1 BOTTLE, PLASTIC (69968-0478-8) 800 ml2018-06-010000-00-00NoNoCurrent