FDA.reportPublic FDA data

Sodium Fluoride Chewable

Product NDC
58657-161
11-digit product format
586570161
Labeler code
58657
Product ID
58657-161_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
.5 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.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui198215, 313036, 315213

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58657-161-102020-02-11C16284748780-19d75b9d0-bae5-f424-e053-dadaa90a57ceSodium Fluoride Chewable Tablets
58657-161-102020-02-11C16284748780-19d75b9d0-bae5-f424-e053-dadaa90a57ceSodium Fluoride Chewable Tablets
58657-161-122020-02-11C16284748780-19d75b9d0-bae5-f424-e053-dadaa90a57ceSodium Fluoride Chewable Tablets
58657-161-122020-02-11C16284748780-19d75b9d0-bae5-f424-e053-dadaa90a57ceSodium Fluoride Chewable Tablets
58657-161-102020-01-31C16284748780-19d75b9d0-bae5-f424-e053-dadaa90a57ceSodium Fluoride Chewable Tablets
58657-161-102020-01-31C16284748780-19d75b9d0-bae5-f424-e053-dadaa90a57ceSodium Fluoride Chewable Tablets
58657-161-122020-01-31C16284748780-19d75b9d0-bae5-f424-e053-dadaa90a57ceSodium Fluoride Chewable Tablets
58657-161-122020-01-31C16284748780-19d75b9d0-bae5-f424-e053-dadaa90a57ceSodium Fluoride Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-161-10Sodium Fluoride Chewable1000 in 1 BOTTLETABLET10007
58657-161-12Sodium Fluoride Chewable120 in 1 BOTTLETABLET1207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-161-10EA - Each58657-1618809a004-6a45-41ac-8da9-336a77ec67a712018-11-06
58657-161-12EA - Each58657-16134f82811-2df7-41c9-ba7f-29c14104337f12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-161SODIUM FLUORIDE CHEWABLE (SODIUM FLUORIDE) TABLET [METHOD PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20241126_e2061541-bf1c-4ee3-afde-36894394dbea.zip

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
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
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
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
58657-161-10586570161101000 TABLET in 1 BOTTLE (58657-161-10) 1000 tablet2018-08-170000-00-00NoNoCurrent
58657-161-1258657016112120 TABLET in 1 BOTTLE (58657-161-12) 120 tablet2018-08-170000-00-00NoNoCurrent