FDA.reportPublic FDA data

Emmi-dent Fresh

Product NDC
63956-004
Requested package NDC
63956-004-01
11-digit product format
639560004
Labeler code
63956
Product ID
63956-004_44d1ed60-1de5-49e0-bfe4-45208180a4e9
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
2019-07-15
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
199 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63956-00463956-004-01IInactivated 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63956-00463956-004-01IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63956-00463956-004-01IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63956-004-012024-12-12C16284748780-11030e365-05ea-111a-e063-dadaa90a10e2Emmi ® -dent Fresh
63956-004-012024-07-30C16284748780-11030e365-05ea-111a-e063-dadaa90a10e2Emmi ® -dent Fresh
63956-004-012024-01-30C16284748780-11030e365-05ea-111a-e063-dadaa90a10e2Emmi ® -dent Fresh

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63956-004-01Emmi-dent Fresh75 mL in 1 TUBEPASTE, DENTIFRICE754
63956-004-01Emmi-dent Fresh1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63956-004EMMI-DENT FRESH (SODIUM FLUORIDE) PASTE, DENTIFRICE [EMAG AG]4Legacy NDC, 2 package rows20241215_1986a759-7dec-4287-884b-556cf314679e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235783sodium fluoride 0.2 % ToothpastePSN1986a759-7dec-4287-884b-556cf314679e4
1235783sodium fluoride 0.002 MG/MG ToothpasteSCD1986a759-7dec-4287-884b-556cf314679e4
1235783sodium fluoride 0.2 % ToothpasteSY1986a759-7dec-4287-884b-556cf314679e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63956-004-01639560004011 TUBE in 1 CARTON (63956-004-01) > 75 mL in 1 TUBE1 tube2019-07-150000-00-00NoNoCurrent