FDA.reportPublic FDA data

NEUTRAMAXX 5000 TCP

Product NDC
63783-501
11-digit product format
637830501
Labeler code
63783
Product ID
63783-501_22fb5942-a2d6-4f0e-8064-a6012e05f43b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Massco Dental A Division of Dunagin Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-08-01
Substance
SODIUM FLUORIDE
Active strength
1.1 g/112g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NEUTRAMAXX 5000 TCP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 g/112g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
392038Internal RxNorm lookup
1191716Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f47cb584-eb8a-4297-ba32-5f435e85aacbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63783-501-04NEUTRAMAXX 5000 TCP112 g in 1 TUBEPASTE, DENTIFRICE1127

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7NEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]2
FLUORIDE IONACTIVE MOIETYQ80VPU408ONEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]2
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XNEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9NEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BNEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]2
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYNEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNNEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]2
SORBITOLINACTIVE INGREDIENT506T60A25RNEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]2
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28NEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RNEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ENEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63783-501NEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]7Current NDC, Legacy NDC, 1 package rows20231218_f47cb584-eb8a-4297-ba32-5f435e85aacb.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NEUTRAMAXX 5000 TCPSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticalsf47cb584-eb8a-4297-ba32-5f435e85aacb2023-12-17WarningsExact identifier
ndc (product): 63783-501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191716NeutraMaxx 500 Plus Turbo 1.1 % Dental GelPSNf47cb584-eb8a-4297-ba32-5f435e85aacb7
392038sodium fluoride 1.1 % ToothpastePSNf47cb584-eb8a-4297-ba32-5f435e85aacb7
1191716sodium fluoride 0.011 MG/MG Toothpaste [Neutramaxx]SBDf47cb584-eb8a-4297-ba32-5f435e85aacb7
392038sodium fluoride 0.011 MG/MG ToothpasteSCDf47cb584-eb8a-4297-ba32-5f435e85aacb7
1191716Neutramaxx 0.011 MG/MG Dental GelSYf47cb584-eb8a-4297-ba32-5f435e85aacb7
1191716Neutramaxx 1.1 % Dental GelSYf47cb584-eb8a-4297-ba32-5f435e85aacb7
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSYf47cb584-eb8a-4297-ba32-5f435e85aacb7
392038sodium fluoride 1.1 % Dental GelSYf47cb584-eb8a-4297-ba32-5f435e85aacb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63783-501-0463783050104112 g in 1 TUBE (63783-501-04) 112 g2011-08-012023-12-31NoNoCurrent