FDA.reportPublic FDA data

Sodium Fluoride

Product NDC
58657-322
11-digit product format
586570322
Labeler code
58657
Product ID
58657-322_41b6cf2b-2810-7774-e063-6394a90ac1fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-08-15
Substance
SODIUM FLUORIDE
Active strength
.5 mg/mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.5 mg/mL

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
315102Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
35dcc144-130d-4ec7-a266-c084008ac70cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-322-50Sodium Fluoride50 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-322-50ML - Milliliter58657-322cd9e95eb-2f5f-4e30-90fd-1a467d86727812018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-322SODIUM FLUORIDE SOLUTION/ DROPS [METHOD PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 1 package rows20241126_35dcc144-130d-4ec7-a266-c084008ac70c.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 FluorideSODIUM FLUORIDEMethod Pharmaceuticals, LLC35dcc144-130d-4ec7-a266-c084008ac70c2025-10-21Warnings, Adverse reactionsExact identifier
ndc (product): 58657-322

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315102sodium fluoride 0.5 MG in 1 mL Oral SolutionPSN35dcc144-130d-4ec7-a266-c084008ac70c6
315102sodium fluoride 1.1 MG/ML Oral SolutionSCD35dcc144-130d-4ec7-a266-c084008ac70c6
315102sodium fluoride 0.11 % Oral DropsSY35dcc144-130d-4ec7-a266-c084008ac70c6
315102sodium fluoride 1.1 MG (fluoride ion 0.5 MG) per ML Oral DropsSY35dcc144-130d-4ec7-a266-c084008ac70c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-322-505865703225050 mL in 1 BOTTLE, DROPPER (58657-322-50) 50 ml2018-08-150000-00-00NoNoCurrent