FDA.reportPublic FDA data

PreviDent 5000 Kids

Product NDC
0126-0311
11-digit product format
001260311
Labeler code
0126
Product ID
0126-0311_ed64b7a2-0604-4737-8077-23622f46a4cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate Oral Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-07-01
Substance
SODIUM FLUORIDE
Active strength
6 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PreviDent 5000 Kids
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE6 mg/mL

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
630194Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
29a110f3-f407-fdfa-4346-937269ca849bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0126-0311-92PreviDent 5000 Kids100 mL in 1 BOTTLE, PLASTICPASTE, DENTIFRICE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0126-0311PREVIDENT 5000 KIDS (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20230906_29a110f3-f407-fdfa-4346-937269ca849b.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
PreviDent 5000 KidsSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.29a110f3-f407-fdfa-4346-937269ca849b2026-06-10Warnings, Adverse reactionsExact identifier
ndc (product): 0126-0311

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630194PreviDent 5000 Plus 1.1 % ToothpastePSN29a110f3-f407-fdfa-4346-937269ca849b2
392038sodium fluoride 1.1 % ToothpastePSN29a110f3-f407-fdfa-4346-937269ca849b2
630194sodium fluoride 0.011 MG/MG Toothpaste [Prevident]SBD29a110f3-f407-fdfa-4346-937269ca849b2
392038sodium fluoride 0.011 MG/MG ToothpasteSCD29a110f3-f407-fdfa-4346-937269ca849b2
630194Prevident 0.011 MG/MG ToothpasteSY29a110f3-f407-fdfa-4346-937269ca849b2
630194PreviDent 1.1 % ToothpasteSY29a110f3-f407-fdfa-4346-937269ca849b2
630194PreviDent 5000 Booster 1.1 % Oral GelSY29a110f3-f407-fdfa-4346-937269ca849b2
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY29a110f3-f407-fdfa-4346-937269ca849b2
392038sodium fluoride 1.1 % Dental GelSY29a110f3-f407-fdfa-4346-937269ca849b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0126-0311-9200126031192100 mL in 1 BOTTLE, PLASTIC (0126-0311-92) 100 ml2023-07-01NoNoCurrent