Emmi-dent Fresh

Product NDC
63956-004
11-digit product format
639560004
Labeler code
63956
Product ID
63956-004_e154bd01-f2ab-4f60-a2a9-aa09d3de8811
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
EMAG AG
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-15
Substance
SODIUM FLUORIDE
Active strength
199 mg/75mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Emmi-dent Fresh
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE199 mg/75mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui1235783

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]4Current NDC, Legacy 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