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 Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui198215, 313036, 315213

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58657-160-122020-02-11C16284748780-19d75b9d0-bae5-f424-e053-dadaa90a57ceSodium Fluoride Chewable Tablets
58657-160-122020-02-11C16284748780-19d75b9d0-bae5-f424-e053-dadaa90a57ceSodium Fluoride Chewable Tablets
58657-160-122020-01-31C16284748780-19d75b9d0-bae5-f424-e053-dadaa90a57ceSodium Fluoride Chewable Tablets
58657-160-122020-01-31C16284748780-19d75b9d0-bae5-f424-e053-dadaa90a57ceSodium 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

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