FDA.reportPublic FDA data

Sodium Fluoride Chewable

Product NDC
58657-160
11-digit product format
586570160
Labeler code
58657
Product ID
58657-160_41b579ba-642e-b6d6-e063-6394a90a8e24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-08-17
Substance
SODIUM FLUORIDE
Active strength
.25 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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.25 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
e2061541-bf1c-4ee3-afde-36894394dbeaAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-02-11Sodium Fluoride Chewable Tablets
2020-02-11Sodium Fluoride Chewable Tablets
2020-01-31Sodium Fluoride Chewable Tablets
2020-01-31Sodium Fluoride Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-160-12Sodium Fluoride Chewable120 in 1 BOTTLETABLET1207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-160-12EA - Each58657-160e9a7d07f-99cc-48b4-a782-a699aab19a4d12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-160SODIUM FLUORIDE CHEWABLE (SODIUM FLUORIDE) TABLET [METHOD PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 1 package rows20241126_e2061541-bf1c-4ee3-afde-36894394dbea.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 FLUORIDEMethod Pharmaceuticals, LLCe2061541-bf1c-4ee3-afde-36894394dbea2025-10-21Warnings, Adverse reactionsExact identifier
ndc (product): 58657-160

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198215fluoride 0.25 MG Chewable TabletPSNbe789a6f-b4b4-4088-aaeb-bcbc6ae1e33b106
198215sodium fluoride 0.55 MG Chewable TabletSCDbe789a6f-b4b4-4088-aaeb-bcbc6ae1e33b106
198215sodium fluoride 0.55 MG (fluoride ion 0.25 MG) Chewable TabletSYbe789a6f-b4b4-4088-aaeb-bcbc6ae1e33b106
198215fluoride 0.25 MG Chewable TabletPSNce6968ce-30ee-48d5-8648-52b4efd38fe8102
198215sodium fluoride 0.55 MG Chewable TabletSCDce6968ce-30ee-48d5-8648-52b4efd38fe8102
198215sodium fluoride 0.55 MG (fluoride ion 0.25 MG) Chewable TabletSYce6968ce-30ee-48d5-8648-52b4efd38fe8102
198215fluoride 0.25 MG Chewable TabletPSNe2061541-bf1c-4ee3-afde-36894394dbea7
313036sodium fluoride 1.1 MG Chewable TabletPSNe2061541-bf1c-4ee3-afde-36894394dbea7
315213sodium fluoride 2.2 MG Chewable TabletPSNe2061541-bf1c-4ee3-afde-36894394dbea7
198215sodium fluoride 0.55 MG Chewable TabletSCDe2061541-bf1c-4ee3-afde-36894394dbea7
313036sodium fluoride 1.1 MG Chewable TabletSCDe2061541-bf1c-4ee3-afde-36894394dbea7
315213sodium fluoride 2.2 MG Chewable TabletSCDe2061541-bf1c-4ee3-afde-36894394dbea7
198215sodium fluoride 0.55 MG (fluoride ion 0.25 MG) Chewable TabletSYe2061541-bf1c-4ee3-afde-36894394dbea7
313036sodium fluoride 1.1 MG (fluoride ion 0.5 MG) Chewable TabletSYe2061541-bf1c-4ee3-afde-36894394dbea7
315213sodium fluoride 2.2 MG (fluoride ion 1 MG) Chewable TabletSYe2061541-bf1c-4ee3-afde-36894394dbea7
315213sodium fluoride 2.21 MG (fluoride ion 1 MG) Chewable TabletSYe2061541-bf1c-4ee3-afde-36894394dbea7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-160-1258657016012120 TABLET in 1 BOTTLE (58657-160-12) 120 tablet2018-08-170000-00-00NoNoCurrent