FDA.reportPublic FDA data

Emmi-dent Whitening

Product NDC
63956-003
11-digit product format
639560003
Labeler code
63956
Product ID
63956-003_21527bb7-b2ba-4c58-998e-7a6a22120feb
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
EMAG AG
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-07-30
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
320 mg/75mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63956-003IInactivated by FDA2026-10-05
excluded packagepackage63956-00363956-003-03IInactivated 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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63956-003-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63956-003-03367a005e9d99…383a685ebd0f…

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-12-18Emmi ® -dent Whitening
2024-07-30Emmi ® -dent Whitening
2024-01-30Emmi ® -dent Whitening
2021-11-15Emmi ® -dent Whitening
2021-01-29Emmi ® -dent Whitening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63956-003-03Emmi-dent Whitening75 mL in 1 TUBEPASTE, DENTIFRICE754
63956-003-03Emmi-dent Whitening1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63956-003EMMI-DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [EMAG AG]4Legacy NDC, 2 package rows20241220_dbc0cfe0-24ef-4ee2-b975-4044624a592f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63956-003-03639560003031 TUBE in 1 CARTON (63956-003-03) > 75 mL in 1 TUBE1 tube2019-07-300000-00-00NoNoCurrent