FDA.reportPublic FDA data

Orbitol

Product NDC
69939-306
11-digit product format
699390306
Labeler code
69939
Product ID
69939-306_90b48bfc-25a3-792d-e053-2995a90a2945
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE
Route
DENTAL
Labeler
COSMOPHARM LTD.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-06-30
Marketing end
2022-02-28
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct69939-306DDiscontinued by firm2026-08-17
excluded packagepackage69939-30669939-306-02DDiscontinued 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 · 24 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 packagepackage69939-306-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69939-306-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69939-306-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69939-306-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69939-306-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69939-306-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69939-306-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69939-306-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69939-306-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69939-306-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69939-306-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69939-306-02557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7IORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
SORBITOLINACTIVE INGREDIENT506T60A25RORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1
ZINC CITRATEINACTIVE INGREDIENTK72I3DEX9BORBITOL (SODIUM MONOFLUOROPHOSPHATE) PASTE [COSMOPHARM LTD.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69939-306-0269939030602145 g in 1 TUBE (69939-306-02) 145 g2016-06-302022-02-28NoNoCurrent