FDA.reportPublic FDA data

Sodium Fluoride Chewable

Product NDC
63629-1132
11-digit product format
636291132
Labeler code
63629
Product ID
63629-1132_619915d1-ea93-464c-beda-732dd419542e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-08-17
Substance
SODIUM FLUORIDE
Active strength
.5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Fluoride Chewable
Listing expiration
2026-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
efb09948-ea45-4fea-a3c5-b98182271066Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1132-1Sodium Fluoride Chewable120 in 1 BOTTLETABLET120106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1132-1EA - Each63629-11328200f8b9-995e-49ca-9519-96850201586412021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1132SODIUM FLUORIDE CHEWABLE (SODIUM FLUORIDE) TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20250309_efb09948-ea45-4fea-a3c5-b98182271066.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
Sodium Fluoride ChewableSODIUM FLUORIDEBryant Ranch Prepackefb09948-ea45-4fea-a3c5-b981822710662024-05-29Warnings, Adverse reactionsExact identifier
ndc (product): 63629-1132

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313036sodium fluoride 1.1 MG Chewable TabletPSNefb09948-ea45-4fea-a3c5-b98182271066106
313036sodium fluoride 1.1 MG Chewable TabletSCDefb09948-ea45-4fea-a3c5-b98182271066106
313036sodium fluoride 1.1 MG (fluoride ion 0.5 MG) Chewable TabletSYefb09948-ea45-4fea-a3c5-b98182271066106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1132-163629113201120 TABLET in 1 BOTTLE (63629-1132-1) 120 tablet2020-10-210000-00-00NoNoCurrent