FDA.reportPublic FDA data

Sodium Fluoride Chewable

Product NDC
72162-1653
11-digit product format
721621653
Labeler code
72162
Product ID
72162-1653_1a735752-a778-4b35-accf-1ea57f1b9c77
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
11bb5a3d-abc5-4460-99d8-09d849491446Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1653-0Sodium Fluoride Chewable1000 in 1 BOTTLETABLET1000102
72162-1653-2Sodium Fluoride Chewable120 in 1 BOTTLETABLET120102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1653-0EA - Each72162-1653ba3c24e7-8bf4-41ab-b31e-98efb6ad7b8c12023-12-05
72162-1653-2EA - Each72162-1653ece0ced0-7508-45ce-8696-9386ec79f0a312023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1653SODIUM FLUORIDE CHEWABLE (SODIUM FLUORIDE) TABLET [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240415_11bb5a3d-abc5-4460-99d8-09d849491446.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 Prepack11bb5a3d-abc5-4460-99d8-09d8494914462025-11-13Warnings, Adverse reactionsExact identifier
ndc (product): 72162-1653

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313036sodium fluoride 1.1 MG Chewable TabletPSN11bb5a3d-abc5-4460-99d8-09d849491446102
313036sodium fluoride 1.1 MG Chewable TabletSCD11bb5a3d-abc5-4460-99d8-09d849491446102
313036sodium fluoride 1.1 MG (fluoride ion 0.5 MG) Chewable TabletSY11bb5a3d-abc5-4460-99d8-09d849491446102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1653-0721621653001000 TABLET in 1 BOTTLE (72162-1653-0) 1000 tablet2018-08-17NoNoCurrent
72162-1653-272162165302120 TABLET in 1 BOTTLE (72162-1653-2) 120 tablet2018-08-17NoNoCurrent