FDA.reportPublic FDA data

Sodium Fluoride Chewable

Product NDC
63629-1131
11-digit product format
636291131
Labeler code
63629
Product ID
63629-1131_1eb38d79-3ea5-4067-a77c-020c3892d436
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
ba5f6fbd-0132-4dac-b047-32f187a2503eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1131-1Sodium Fluoride Chewable1000 in 1 BOTTLETABLET1000105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1131-1EA - Each63629-1131f56b0106-0139-4a8e-aa4f-b0d7a6c4cedd12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1131SODIUM FLUORIDE CHEWABLE (SODIUM FLUORIDE) TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240423_ba5f6fbd-0132-4dac-b047-32f187a2503e.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 Prepackba5f6fbd-0132-4dac-b047-32f187a2503e2025-11-13Warnings, Adverse reactionsExact identifier
ndc (product): 63629-1131

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313036sodium fluoride 1.1 MG Chewable TabletPSNba5f6fbd-0132-4dac-b047-32f187a2503e105
313036sodium fluoride 1.1 MG Chewable TabletSCDba5f6fbd-0132-4dac-b047-32f187a2503e105
313036sodium fluoride 1.1 MG (fluoride ion 0.5 MG) Chewable TabletSYba5f6fbd-0132-4dac-b047-32f187a2503e105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1131-1636291131011000 TABLET in 1 BOTTLE (63629-1131-1) 1000 tablet2018-08-170000-00-00NoNoCurrent