FDA.reportPublic FDA data

ASTONEA -SODIUM FLUORIDE

Product NDC
77338-091
11-digit product format
773380091
Labeler code
77338
Product ID
77338-091_ef052828-db6d-d7a8-e053-2995a90a9031
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Floride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-01-15
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct77338-091IInactivated by FDA2026-10-05
excluded packagepackage77338-09177338-091-38IInactivated 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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage77338-091-388af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-091-38834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-091-381332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77338-091-382024-06-25C16284748780-11030e365-315d-111a-e063-dadaa90a10e2astonea -sodium fluoride
77338-091-382024-01-30C16284748780-11030e365-315d-111a-e063-dadaa90a10e2astonea -sodium fluoride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-091-38ASTONEA -SODIUM FLUORIDE43 g in 1 TUBEPASTE, DENTIFRICE433

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-091ASTONEA -SODIUM FLUORIDE (SODIUM FLORIDE) PASTE, DENTIFRICE [ASTONEA LABS PRIVATE LIMITED]3Legacy NDC, 1 package rows20240627_e69bc270-e909-1139-e053-2995a90a039b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSNe69bc270-e909-1139-e053-2995a90a039b3
245598sodium fluoride 0.0022 MG/MG ToothpasteSCDe69bc270-e909-1139-e053-2995a90a039b3
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSYe69bc270-e909-1139-e053-2995a90a039b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-091-387733800913843 g in 1 TUBE (77338-091-38) 43 g2015-01-150000-00-00NoNoCurrent