FDA.reportPublic FDA data

Fluoride

Product NDC
75826-164
11-digit product format
758260164
Labeler code
75826
Product ID
75826-164_47a68277-53e0-538f-e063-6394a90aa82c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
WINDER LABORATORIES, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-01-01
Substance
SODIUM FLUORIDE
Active strength
.5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.5 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198215Internal RxNorm lookup
313036Internal RxNorm lookup
315213Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0df8f1aa-f3ef-9f59-e063-6294a90a0666Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75826-164-20Fluoride120 in 1 BOTTLETABLET, CHEWABLE1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75826-164FLUORIDE (SODIUM FLUORIDE) TABLET, CHEWABLE [WINDER LABORATORIES, LLC]1Current NDC, 1 package rows20240103_0df8f1aa-f3ef-9f59-e063-6294a90a0666.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
FluorideSODIUM FLUORIDEWINDER LABORATORIES, LLC0df8f1aa-f3ef-9f59-e063-6294a90a06662026-01-05Warnings, Adverse reactionsExact identifier
ndc (product): 75826-164

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198215fluoride 0.25 MG Chewable TabletPSN0df8f1aa-f3ef-9f59-e063-6294a90a06662
313036sodium fluoride 1.1 MG Chewable TabletPSN0df8f1aa-f3ef-9f59-e063-6294a90a06662
315213sodium fluoride 2.2 MG Chewable TabletPSN0df8f1aa-f3ef-9f59-e063-6294a90a06662
198215sodium fluoride 0.55 MG Chewable TabletSCD0df8f1aa-f3ef-9f59-e063-6294a90a06662
313036sodium fluoride 1.1 MG Chewable TabletSCD0df8f1aa-f3ef-9f59-e063-6294a90a06662
315213sodium fluoride 2.2 MG Chewable TabletSCD0df8f1aa-f3ef-9f59-e063-6294a90a06662
198215sodium fluoride 0.55 MG (fluoride ion 0.25 MG) Chewable TabletSY0df8f1aa-f3ef-9f59-e063-6294a90a06662
313036sodium fluoride 1.1 MG (fluoride ion 0.5 MG) Chewable TabletSY0df8f1aa-f3ef-9f59-e063-6294a90a06662
315213sodium fluoride 2.2 MG (fluoride ion 1 MG) Chewable TabletSY0df8f1aa-f3ef-9f59-e063-6294a90a06662
315213sodium fluoride 2.21 MG (fluoride ion 1 MG) Chewable TabletSY0df8f1aa-f3ef-9f59-e063-6294a90a06662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
75826-164-2075826016420120 TABLET, CHEWABLE in 1 BOTTLE (75826-164-20) 2024-01-01NoNoCurrent